on 15 March 2024 | By Kevin Rowland, RQM+ Director of R&D
Extractables and leachables are potentially hazardous chemicals that a patient can be exposed to when using medical devices or drug products. These chemicals may be present as impurities in the materials used, but also may be introduced during manufacturing or storage....
Read Moreon 14 March 2024 | By Richard Freeman, Director, Global Audit Practice
Staying ahead of compliance and regulatory requirements needs to be a top priority for MedTech companies. Audits are an integral part of maintaining these standards, but can often be seen as stressful and time-consuming events. However, the perspective shifts when these are...
Read Moreon 11 March 2024 | By Niki Spaniel, RAC, Principal, CPMP, Practice Manager and Anastassia Young, MS, Senior Consultant
The FDA Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices program may benefit manufacturers in reducing the burden of medical device reporting (21 CFR Part 803, under 21 CFR 80.309(b) where real world data/evidence is being collected,...
Read Moreon 29 February 2024 | By Margot Borgel, Director, IVD Global Regulatory Affairs
Team-NB recently released a position paper regarding the classification of devices to detect SARS-CoV-2. These devices are currently cited in the MDCG 2020-16 classification guidance as an example of a device falling under Rule 1, 2nd indent, which states: "Devices intended to...
Read Moreon 20 February 2024 | By Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence and Innovation and James Wrenn, Director, Solutions Delivery RQM+
The impending phase-out of per- and polyfluoroalkyl substances (PFAS) presents a significant challenge for MedTech companies. After all, PFAS has been an integral component in manufacturing many MedTech devices.
Read Moreon 12 February 2024 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
Published in December last year, MDCG 2023-7 clarifies when clinical investigations are not mandatory for Class III and implantable devices. MDCG 2023-7 also shares updated guidelines for when data from equivalent devices may be used in a clinical evaluation under the EU Medical...
Read Moreon 6 February 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
What is regulatory intelligence? Ok, so what on earth are we talking about when we say regulatory intelligence? There are no formal definitions for regulatory intelligence in regulations or standards relating to medical devices or in vitro diagnostic devices. Without delving...
Read Moreon 3 January 2024 | By Kevin Rowland, RQM+ Director of R&D
While biocompatibility testing is necessary to develop safe MedTech devices, several issues complicate the process. From the initial study setup to deriving accurate conclusions, complications can arise at each testing stage. That’s bad news. Any testing obstacles can delay...
Read Moreon 21 December 2023 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
Introduction to the New MDCG Guidance A new MDCG guidance document has been published today, providing welcome clarification regarding the practical application of EU MDR Articles 61(4) – (6). This new guidance, "MDCG 2023-7: Guidance on exemptions from the requirement to...
Read Moreon 12 December 2023 | By Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence and Innovation and James Wrenn, Director, Solutions Delivery RQM+
Major per- and polyfluoroalkyl substances (PFAS) suppliers are beginning to exit the market due to significant environmental, health, regulatory, and legal concerns. That’s mostly a good thing! While PFAS are used in an incredible array of consumer products, including medical...
Read Moreon 5 December 2023 | By Kevin Rowland, RQM+ Director of R&D
In the MedTech sector, the biocompatibility of materials is critical for patient safety and product efficacy. Every material needs to be tested, with suppliers often providing quality and biocompatibility assurances.
Read Moreon 16 November 2023 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
Introduction We have previously talked about the upcoming 2024 EU deadlines for QMS compliance and notified body applications for the EU MDR 2017/745 (5 Essential Tips for EU MDR Compliance and How to Meet the EU's 2024 MDR Deadlines), but what is needed beyond that? What if you...
Read Moreon 10 November 2023 | By Kevin Rowland, RQM+ Director of R&D
For any MedTech company, the goal of developing products that are both effective and safe is at the heart of their mission. But as these companies build their products, they inevitably encounter testing challenges. Comprehensive testing, while crucial, often comes with a hefty...
Read Moreon 1 October 2023 | By Eric Pauls, Chief Customer Officer
From navigating the complex regulatory environment to implementing the right quality controls — MedTech companies face many challenges in getting their products to market. These challenges lengthen product development cycles and increase the time it takes to get vital...
Read Moreon 30 August 2023 | By Amie Smirthwaite, Ph.D., RQM+ Senior VP of Intelligence & Innovation and Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence & Innovation
To begin, a cautionary statement... The MDR transition timeline extension is not automatically applied to every legacy device! The timeline extension is conditional in nature, and there are a few key requirements that must be satisfied before manufacturers can benefit from this...
Read Moreon 23 August 2023 | By Margot Borgel, Ph.D.
Introduction The pathway to IVDR certification for companion diagnostics (CDx) can be overwhelming due to the complexity of the certification process. Certification from a notified body was not previously required, as they were self-certified under IVDD. In addition,...
Read Moreon 17 July 2023 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
Introduction Regulation 2023/607 removed the May 2024 transition deadline for medical devices transitioning from MDD/AIMDD to MDR 2017/745. The end of the transition period was pushed back to 2026, 2027 or 2028, depending on the classification of the device.
Read Moreon 5 July 2023 | By Daniel Lace, MD, Chief Medical Officer
This blog post explores the CMS and AHRQ's proposed TCET pathway, which aims to improve beneficiary access, reduce coverage uncertainty, encourage evidence development and coordinate benefit categories for emerging technologies. It also discusses eligibility criteria for...
Read Moreon 9 December 2022 | By Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence & Innovation
Earlier today, in the EPSCO meeting, all EU member states unanimously agreed to the proposal recommendations listed below. Belgium asked for a detailed root cause analyses of why the MDR roll out finds itself where it is today. Malta has asked for one single date as opposed to a...
Read Moreon 6 December 2022 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
Digital health devices are no longer new on the scene, but the regulatory landscape continues to evolve. As predicted in our blog post earlier this year, the latest development is new U.S. Food and Drug Administration (FDA) guidance documents for digital health devices that were...
Read Moreon 29 November 2022 | By Kevin Go, MBA, RAC, CQA, RQM+ Senior Principal
Medical devices that fall into the category of software as a medical device (SaMD) are on the rise as technology continues to evolve. Although these products have proven to be highly beneficial to patients and end users, manufacturers must overcome many regulatory challenges.
Read Moreon 21 November 2022 | By Andrew Tarnaris, M.D. MD (Res) FRCS (NeuroSurg), RQM+ Medical Director
A new opinion (CECP-2022-000222) provided under the Clinical Evaluation Consultation Procedure (CECP) was recently published by the European Commission. Here are some things worth noting, a summary to digest and lessons learnt both for manufacturers and notified bodies alike.
Read Moreon 8 November 2022 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
As an industry, medical device manufacturers and regulators have an obligation to ensure that children are not left behind when it comes to the innovation and development of products to treat childhood conditions and diseases. The reality is that the innovation of pediatric...
Read Moreon 2 November 2022 | By Rem Siekmann, RQM+, Ronald Sills, RQM+
The transition to EU MDR and EU IVDR has come with a steep learning curve for all in the industry, including both manufacturers and notified bodies. With hundreds of MDR and IVDR technical files under our belts, we have learned a lot about the most common findings — and how to...
Read Moreon 3 October 2022 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
As part of its commitment to shift to electronic submission, the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) launched the Customer Collaboration Portal (CCP) in July 2022. The CCP allows medical device manufacturers to...
Read Moreon 8 September 2022 | By Andrew Tarnaris, M.D. MD (Res) FRCS (NeuroSurg), RQM+ Medical Director
Pappalardo F et al. published a recent paper (in the IEEE JOURNAL OF BIOMEDICAL AND HEALTH INFORMATICS) advocating for a roadmap towards the CE marking of medical devices based on in silico trials. In silico trials simply mean the use of computer modelling and simulation in...
Read Moreon 31 August 2022 | By RQM+ Subject Matter Experts
The annual RAPS Convergence is coming soon, and our team is excited to actively contribute to this year’s program with several speaking sessions. We’re covering wide-ranging regulations for medical devices and in vitro diagnostics in the EU and U.S. Here’s a preview of what to...
Read Moreon 27 July 2022 | By Kevin Go, MBA, RAC, CQA, RQM+ Senior Principal
As part of FDA Center for Devices and Radiological Health's (CDRH) Digital Transformation Initiative, several new tools have been released to strengthen the regulatory submission process. One of these tools is the Customer Collaboration Portal (CCP), which allows users to track...
Read Moreon 26 July 2022 | By Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation, IVD
The transition from IVDD (98/79/EC) to IVDR (EU 2017/746) has been overwhelming for many manufacturers, especially those that have never worked with a notified body because they were previously able to self-certify under the IVDD. Many are now realizing that the IVDR notified...
Read Moreon 14 June 2022 | By Ashley Clark, MS, RAC (US, Medical Device), RQM+ Principal Specialist and Nancy Morrison, RAC, RQM+ Executive Director, Regulatory & Quality Consulting Services
Summary Genus Medical Technologies upset the US FDA classification schema for imaging agents such as barium sulfate in the landmark litigation ruling1 in the drug turned device manufacturer’s favor that only products meeting the definition of a drug must be regulated as such....
Read Moreon 7 June 2022 | By Kevin Go, Project Engineer and Nancy Morrison, Executive Director Regulatory and Quality Consulting Services
The FDA’s proposed rule to align its quality system regulation with ISO 13485 has the industry buzzing. What does it mean for medical device and IVD manufacturers? Let’s take a closer look at the proposed changes and what they might mean for manufacturers if they are adopted.
Read Moreon 1 June 2022 | By Anike Freeman, RQM+ Principal
As part of the FDA Reauthorization Act (FDARA) and the Medical Device User Fee Amendments (MDUFA IV) of 2017, the U.S. Food and Drug Administration (FDA) committed to developing electronic submission templates. The intent of these templates is to provide guided submission...
Read Moreon 18 May 2022 | By Jan Kloiber, Senior Principal Specialist and Celeste Maksim, Chief of Staff, Clinical and Post-Market Services
May 2022 is the one-year milestone for EU MDR and the date of application for IVDR. For medical devices that have already been approved under MDR, annual periodic safety update reports (PSURs) are due for Class IIb and III devices. Since this is the first year and there is still...
Read Moreon 10 May 2022 | By Andrew Tarnaris, M.D. MD (Res) FRCS (NeuroSurg), RQM+ Medical Director
State of the art (SOTA) is a key element of the technical documentation required for MDR/IVDR certification. As a new requirement for devices in lower-risk classes, many manufacturers are struggling to provide SOTA context that meets notified body expectations. Whether for new...
Read Moreon 27 April 2022 | By RQM+ Subject Matter Experts
State of the art (SOTA) is a key piece of the IVDR puzzle. Like many of the other required elements, it touches multiple sections of your technical documentation and must be consistently addressed throughout.
Read Moreon 21 April 2022 | By Bethany Chung, Ph.D., RAC, RQM+ Principal Regulatory Scientist and Jaishankar (Jai) Kutty, Ph.D., RQM+ VP, Intelligence & Innovation
Under the Medical Device Regulation (2017/745) (MDR), demonstrating clinical benefit and quantifying benefit-risk ratios are critical to compliance. A medical device must not be placed on the market if the benefit of the product does not outweigh the risk in a clearly quantified...
Read Moreon 13 April 2022 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
IVD manufacturers have had to make significant improvements to their risk files since the days of IVDD. What was once the reality—static and often incomplete files that hardly changed after being placed on the market—is no longer acceptable. However, despite making major headway...
Read Moreon 23 March 2022 | By RQM+ Subject Matter Experts
Until recently, many IVD manufacturers were able to make changes to the design or intended use of their devices with minimal consequences under IVDD (98/79/EC). With the transition to IVDR and the date of application just around the corner, that time window is quickly closing....
Read Moreon 10 March 2022 | By Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence & Innovation
In the EU, a device is considered to be equivalent if and only if it fulfills all the requirements of technical, clinical, and biological equivalence. Of these, biological equivalence tends to be the most nuanced and can be a confusing topic for medical device...
Read Moreon 22 February 2022 | By Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)
Since the beginning of the COVID-19 pandemic, CDRH has dealt with an unprecedented workload to ensure timely access to high quality health products that are essential to the nation’s pandemic response. Two years later, the pandemic response remains a top priority as CDRH...
Read Moreon 21 February 2022 | By Amie Smirthwaite BEng, PhD, RQM+ Senior Vice President, Intelligence & Innovation; Nancy Morrison, RQM+ Vice President, Intelligence & Innovation
2021 was another big year in the European regulatory realm as EU MDR and IVDR implementation continued to roll out. Let’s take a look at the highlights and lessons learned that we can apply as we go into 2022.
Read Moreon 17 February 2022 | By Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation, IVD
The MDCG guidance 2022-3 Verification of manufactured class D IVDs by notified bodies was issued earlier this week on the 15th of February 2022. This guidance is important for manufacturers because it provides a detailed specification of the requirements for the testing plan and...
Read Moreon 9 February 2022 | By RQM+ Subject Matter Experts
RQM+ is excited to announce the addition of Dr. Heike Moehlig-Zuttermeister as IVD Vice President Intelligence and Innovation. Heike joins us after nearly eight years at BSI, where she held leadership roles within the IVD team.
Read Moreon 7 February 2022 | By Brian Hockett, RQM+ and Chad Quistad, RQM+
Advancements in technology over the past several decades have naturally led to advancements in healthcare. Software as a medical device (SaMD) is particularly poised for growth with one of the latest advancements: the Internet of Things (IoT). Because of this and other factors,...
Read Moreon 2 February 2022 | By Heike Moehlig-Zuttermeister, PhD, RQM+ VP Intelligence and Innovation, IVD
The first three Performance Evaluation Consultation Procedure (PECP) views have been published for a professional SARS-CoV-2 immunoassay and a professional nucleic acid testing (NAT) assay as well as a near-patient testing NAT SARS-CoV-2 product. Considering the actual...
Read Moreon 31 January 2022 | By RQM+ Subject Matter Experts
“RQM+ is always the first resource I think of when assistance is needed. In addition I cannot state how grateful I am for your organizations thought leadership and resources/content. It’s best in class!” In 2021, we launched the RQM+ Knowledge Center as your one-stop-shop to...
Read Moreon 26 January 2022 | By Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)
“It’s tough to make predictions, especially about the future.” Whether baseball Hall of Famer-slash-philosopher Yogi Berra actually said these words or not, the sentiment rings true, as anyone who has tried to predict the course of the COVID-19 pandemic would know. Predicting...
Read Moreon 21 January 2022 | By Jonathan Gimbel, PhD, RQM+ Executive Director, Technical Leadership, Clinical & Post-Market Practice
The EU MDR date of application has come and gone, and most manufacturers are well aware of the new requirements. However, awareness does not necessarily equal effective implementation. One of the main challenges of MDR compliance is creating a strategy that integrates the work...
Read Moreon 17 January 2022 | By RQM+ Subject Matter Experts
While we are happy and relieved for the IVD industry to have an extension to the IVDR transition period, we’re concerned that the announcement may result in a misperception that there is plenty of time to get the work done.
Read Moreon 10 January 2022 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
With the rollout of EU MDR and IVDR, manufacturers are facing new challenges, especially when it comes to technical documentation review. Medical device and IVD manufacturers are accustomed to doing mock audits for quality systems and ISO certification, but these types of...
Read Moreon 5 January 2022 | By Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer)
Looking back to 2020, as the COVID-19 pandemic gripped the world, much of the FDA’s focus turned to their response to the public health emergency. CDRH in particular reviewed thousands of emergency use authorization (EUA) applications and worked to facilitate the development and...
Read Moreon 21 December 2021 | By RQM+ Subject Matter Experts
Under the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), every IVD must have a Performance Evaluation Report (PER). PERs consist of three pillars: scientific validity, analytical performance and clinical performance. Collating data to satisfactorily address...
Read Moreon 20 December 2021 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
About this article: Could there be more scope for use of equivalence data under EU MDR than you may have thought? Dr. Amie Smirthwaite, Sr. VP of Global Intelligence & Innovation at RQM+, EU MDR expert, and member of the working groups that authored MDCG 2020-5 and 2020-6, has...
Read Moreon 17 December 2021 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
The world of medical device regulation has seen immense change in past years. The EU MDR has been at the forefront of every agenda for some time – and the one-year deadline delay provided valuable extra time for businesses to get their act together. That one-year delay also...
Read Moreon 16 December 2021 | By RQM+ Subject Matter Experts
The next key regulatory milestone for manufacturers with products on the European market is the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). A critical stage of IVDR planning is for manufacturers to assess whether they have enough clinical and performance...
Read Moreon 14 December 2021 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
What do we know so far about post-Brexit medical device regulation? With the new European MDR and IVDR regulations at the forefront of every conversation across the medical device industry, the emerging UK regime may have been overlooked as another pending compliance challenge....
Read Moreon 3 December 2021 | By Nancy Morrison, RQM+
In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report, which is similar to the post-market Periodic Benefit-Risk...
Read Moreon 30 November 2021 | By Nancy Morrison, RQM+
The recently released guidance on classification of medical devices is very concerning for manufacturers with spinal implantable medical devices. MDCG 2021-24 appears to have classified many spinal fusion devices that were previously thought to be Class IIb as Class III. This...
Read Moreon 17 November 2021 | By Jonathan Gimbel, PhD, RQM+ Executive Director, Technical Leadership, Clinical & Post-Market Practice
As guidance committees, manufacturers, and notified bodies continue to interpret the EU MDR, some areas remain fuzzy. Well-established technology (WET) is high on the list of definitions that are disputed as notified bodies seem to have a different interpretation than the...
Read Moreon 8 November 2021 | By RQM+ Subject Matter Experts
In case you missed it, the latest presentation in our webinar series covers the new requirements under EU MDR and IVDR: the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP), respectively. It’s no surprise that manufacturers are...
Read Moreon 27 October 2021 | By Jonathan Gimbel, PhD, RQM+ Executive Director, Technical Leadership, Clinical & Post-Market Practice
The rollout of the EU MDR has created new challenges for medical device manufacturers, including those that have had devices on the market for a long time. One area of increased focus is the need to quantitatively establish the clinical benefits to patients from the device based...
Read Moreon 25 October 2021 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 19 October 2021 | By RQM+ Subject Matter Experts
Background The COVID-19 pandemic has led to unprecedented challenges for the In Vitro Diagnostic Regulation (IVDR) implementation impacting both manufacturers and key European Union (EU) infrastructure. On one hand, manufacturers were faced with staff shortages impacting their...
Read Moreon 12 October 2021 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
Now that medical device manufacturers have begun to implement MDR-compliant post-market surveillance (PMS) systems, it is a good time to take stock of common areas of difficulty and inefficiency, and consider how best to address these. Even manufacturers who are continuing to...
Read Moreon 8 October 2021 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the...
Read Moreon 5 October 2021 | By Celeste Maksim, PhD, RAC, RQM+
Following the May 2021 deadline, medical device manufacturers now have an MDR-compliant post-market surveillance (PMS) system in place. However, there are still many issues and questions around this topic which need addressing.
Read Moreon 27 September 2021 | By Jan Kloiber, RQM+ Principal
Manufacturers have relied on guidance from the Medical Device Coordination Group and similar organizations to interpret many of the new regulations under EU MDR and IVDR. However, guidance has not been provided for every aspect of the regulation, and application deadlines have...
Read Moreon 21 September 2021 | By RQM+ Subject Matter Experts
RQM+ is excited to announce the addition of Dr. Andrew Tarnaris as Medical Director. With a background as both a medical doctor and notified body clinical expert, he represents an excellent example of our unique combination of clinical and regulatory experience.
Read Moreon 13 September 2021 | By Ashley (Ash) Clark, MS, RAC, RQM+
A new guidance document (MDCG 2020-21) has been published on the 3rd of August by the Medical Device Coordination Group (MDCG) pertaining to performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices. This document provides extensive details on what is expected for...
Read Moreon 9 September 2021 | By RQM+ Subject Matter Experts
The introduction of MDR caused a major transformation in the medical device industry. Manufacturers continue to grapple with all elements of compliance, but clinical evaluation presents unique challenges. RQM+ is committed to helping clients navigate these challenges with former...
Read Moreon 30 August 2021 | By Stephen Biernacki
It is that time of year again for RAPS Convergence and we cannot wait to join the largest annual gathering of regulatory professionals from around the world. The conference will be held virtually this year from 12-15 September 2021 and we will be joining in the fun with a Q&A...
Read Moreon 16 August 2021 | By Lisa Casavant, RQM+ EVP
Investment to Accelerate Growth and Expand Consulting Services for Medical Device and Diagnostics Manufacturers
Read Moreon 2 August 2021 | By RQM+ Subject Matter Experts
THE PROJECT A leading global company offering medical technology, services, and solutions engaged RQM+ to help four business units prepare for the EU Medical Device Regulation (MDR). Specifically, RQM+ is focused on assessing and remediating gaps in MDD technical files and...
Read Moreon 28 June 2021 | By Nancy Morrison, RQM+
EU IVDR 2017/746 includes a requirement to write a summary of safety and performance (SSP) for Class C and D IVDs. This is a new requirement that wasn’t included in IVDD. The goal of this requirement is to enhance transparency and provide adequate public access to summarized...
Read Moreon 21 June 2021 | By RQM+ Subject Matter Experts
The latest addition to our webinar series covers the biggest challenges in IVDR compliance. With hundreds of MDR submissions under our belts and a number of clients who have already received findings from their IVDR applications, we have learned a lot about the regulation, the...
Read Moreon 10 June 2021 | By Kim Platt
Medical device recalls are daunting in many ways—manufacturers dread them, competitors love them, and patients don’t always understand them. A medical device recall could be a response to patient safety concerns or to unanticipated negative trends. All manufacturers should...
Read Moreon 1 June 2021 | By RQM+ Subject Matter Experts
Food and Drug Administration (FDA) inspections are stressful, especially if your documentation isn’t audit-ready. Creating and maintaining a compliant design history file (DHF) will help ensure that when the time comes, you’ll be ready for an FDA inspection that results in...
Read Moreon 27 May 2021 | By Stephanie Martinez
The European Union’s new In Vitro Diagnostic Regulation (IVDR) May 2022 implementation date is fast approaching. If you sell IVDs in multiple markets, it may be challenging to determine the differences between the IVD regulations in the U.S., the existing IVDD, and the new IVDR....
Read Moreon 26 May 2021 | By Nancy Morrison, RQM+
The European Union (EU) Medical Device Regulation (MDR) 2017/745 date of application is here! To celebrate the incredible effort medical device manufacturers have put in so far to get to this point, we have compiled a brief review of the remaining EU MDR timeline and a list of...
Read Moreon 25 May 2021 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 20 May 2021 | By Nancy Morrison, RQM+
Whether you are used to working with a notified body or the MDR/IVDR requirements no longer allow you to self-certify and it’s all new to you, it is more important than ever to optimize your technical documentation. Notified bodies are already swamped with MDR submissions, and...
Read Moreon 18 May 2021 | By Nancy Morrison, RQM+
In the EU, CE marking is the system used to demonstrate that products meet the region’s requirements for safety, health, and environmental protection. When a product is labeled with the CE marking, it can be freely traded in the European Economic Area (EEA) without restrictions.
Read Moreon 5 May 2021 | By Deven Hennon, RQM+
We are excited to host a panel discussion during next week's virtual RAPS Euro Convergence 2021! Join our expert panel for our session on IVDR Implementation Best Practices and Challenges. See the schedule here and find more details on our session below.
Read Moreon 28 April 2021 | By Rem Siekmann, RQM+
Maintaining regulatory and quality compliance across multiple markets is challenging. In addition to meeting stringent regulatory requirements, manufacturers must also submit to regular quality system audits. When operating in multiple markets, this often means a busy audit...
Read Moreon 28 April 2021 | By Rem Siekmann, RQM+
In the regulatory world, standards are essentially recommended processes that have been developed by subject matter experts with the aim of describing the best possible way to meet an end goal. For example, quality management standards are designed to improve efficiencies and...
Read Moreon 28 April 2021 | By Chad Quistad, RQM+
As the underlying risk management process for medical devices, the ISO 14971 standard is a critical component of regulatory and quality compliance. When new versions are released and harmonized, it’s up to manufacturers to learn about the changes to update systems accordingly....
Read Moreon 28 April 2021 | By Celeste Maksim, PhD, RAC, RQM+
The requirement for a periodic safety update report (PSUR) or post-market surveillance report (PMSR) is new under EU MDR and EU IVDR. MDD and IVDD had post-market requirements, but the MDR and IVDR requirements are more formal, and for most classes, these reports must be updated...
Read Moreon 28 April 2021 | By Melissa DeHass, RQM+
As we complete regulatory submissions under MDR, we continue to learn from notified body feedback and audit findings. These lessons learned are captured and disseminated throughout the RQM+ team to build our unrivaled collective knowledge, but we also believe in sharing this...
Read Moreon 28 April 2021 | By Nancy Morrison, RQM+
CE marking is the system used in the EU to indicate that products meet the region’s safety, health, and environmental protection requirements. Products labeled with the CE marking can be freely traded in the European Economic Area without restrictions.
Read Moreon 28 April 2021 | By Nancy Morrison, RQM+
EU MDR 2017/745 includes a requirement to write a summary of safety and clinical performance (SSCP) for implantable and Class III devices. Although this is still a relatively new requirement, RQM+ has already gained valuable experience preparing SSCPs on behalf of our clients....
Read Moreon 26 April 2021 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 8 April 2021 | By Stephen Biernacki
Update: the RAPS + RQM+ webcast is now available on demand here. Understand the ins and outs of PMCF user feedback surveys by registering for two upcoming and free RQM+ webinars: April 27 – PMCF User Feedback Surveys: Practical solutions for leveraging user feedback surveys as...
Read Moreon 19 March 2021 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 22 February 2021 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 17 February 2021 | By Stephen Biernacki
In this webinar we will provide practical solutions for leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.
Read Moreon 16 February 2021 | By Ashley (Ash) Clark, MS, RAC, RQM+
RQM+ experts summarize the MDCG guidance from November 2020, Guidance on Classification Rules for the in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, to aid IVD industry stakeholders in understanding, planning, and executing compliance to the IVDR by May...
Read Moreon 1 February 2021 | By Deven Hennon, RQM+
February 1, 2021 - RQM+ welcomes Dr. Jai Kutty.
Read Moreon 21 January 2021 | By Kevin Go, MBA, RAC, CQA, RQM+ Senior Principal
U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document.
Read Moreon 18 January 2021 | By Stephen Biernacki
This on-demand webinar will address best practices in scientific database search techniques that can be applied in the performance of a clinical evaluation.
Read Moreon 11 January 2021 | By Deven Hennon, R&Q
We are proud to announce that R&Q and Maetrics have merged and rebranded to form the world's leading medical device and diagnostics consultancy. Check out the full press release below or visit our new brand microsite at RQMplus.com
Read Moreon 4 January 2021 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 15 December 2020 | By RQM+ Subject Matter Experts
When to use Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.
Read Moreon 7 December 2020 | By Deven Hennon, R&Q
7 December 2020 Update: After some delays the first module of the European database on medical devices (EUDAMED) is live! Here is what you need to know about the Actor registration module, the first of six modules in EUDAMED: WHO can use this module? Economic operators...
Read Moreon 1 December 2020 | By Deven Hennon, R&Q
1 December 2020 - Getting started with Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.
Read Moreon 23 November 2020 | By RQM+ Subject Matter Experts
RQM+ sponsored both RAPS U.S. and Euro Convergence conferences in 2020 and we also led and provided subject matter experts for two panel discussions. Our experts pulled together the highlights from both conferences and summarized them by category for our readers.
Read Moreon 18 November 2020 | By Lisa Casavant, RQM+ EVP
18 November 2020 - A challenging year makes it more important than ever to be supporting and serving our communities.
Read Moreon 10 November 2020 | By Celeste Maksim, PhD, RAC, RQM+
10 November 2020 - RQM+ experts have come up with a list of our top ten suggestions for mastering Post-Market Clinical Follow-up ("PMCF") Surveys under the European Union's Medical Device Regulation.
Read Moreon 30 October 2020 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 28 October 2020 | By Deven Hennon, R&Q
28 October 2020 - October is National Cybersecurity Awareness month, so we think there is no better time to talk about FDA’s new qualified tool for assessing medical device cybersecurity vulnerabilities and why using it makes sense to help you #BeCyberSmart.
Read Moreon 26 October 2020 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 23 October 2020 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 21 October 2020 | By Nancy Morrison, RQM+
R&Q's August 2020 webinar focused on Economic Operators: Addressing the EU MDR and IVDR requirements head-on. In this follow-up blog post, our knowledgeable MDR and IVDR regulatory experts sat down to answer audience questions.
Read Moreon 16 October 2020 | By Stephen Biernacki
Having strong integrated complaint and risk management processes is about more than just compliance. Watch this webinar and learn critical strategies and tactics for success. As with every R&Q webinar, all registrants will receive access to the slides and recording.
Read Moreon 14 October 2020 | By Deven Hennon, R&Q
14 October 2020 - The National Standards Authority of Ireland (NSAI) has adopted December 2020 as the expected implementation date for EN ISO 14971:2019.
Read Moreon 7 October 2020 | By Deven Hennon, R&Q
7 October 2020 - A short conversation with the European Commission provides details on when we can expect access to their expert panels.
Read Moreon 1 October 2020 | By Deven Hennon, R&Q
1 October 2020 - As the end of the BREXIT transition period nears, the UK government has released a proposed regime on the regulation of medical devices.
Read Moreon 10 September 2020 | By Deven Hennon, R&Q
We are proud to announce that we have acquired Maetrics, a leader in life sciences quality and regulatory consulting. Check out the full press release below or visit ourRAPS Convergence 2020 announcement page for more information.
Read Moreon 8 September 2020 | By Stephen Biernacki
Whether you’re just starting to plan your IVDR program (or not sleeping well because you haven’t started yet) or well into EU MDR but ready to plan post-market surveillance activities, our September webinar will be helpful. All registrants will receive access to the slides and...
Read Moreon 3 September 2020 | By Deven Hennon, R&Q
3 September 2020 - Training Workshops brought to you by the Subject Matter Experts at Regulatory & Quality Solutions.
Read Moreon 30 August 2020 | By Stephen Biernacki
RQM+ is counting down the days until we can join the RAPS community at the virtual RAPS Convergence 2020 on 13-16 September 2020. As many of you know, the Convergence is the largest annual gathering of regulatory professionals from around the world. While we'll miss interacting...
Read Moreon 24 August 2020 | By Stephen Biernacki
Note: A version of this post was initially published for the flagship online publication of RAPS, Regulatory Focus™ In an effort to further support the medical device industry during the COVID-19 pandemic, we've been spreading love more than ever in one of the best ways we know...
Read Moreon 11 August 2020 | By Deven Hennon, R&Q
11 August 2020 - We sat down to with R&Q's Ruthanne Vendy, RAC to talk about her experience as a contributing author to the Regulatory Affairs Professionals Society’s (RAPS) Fundamentals of EU Regulatory Affairs, Ninth Edition.
Read Moreon 3 August 2020 | By Stephen Biernacki
In our August 2020 webinar you'll learn about the EU MDR and IVDR requirements for economic operators.
Read Moreon 29 July 2020 | By Deven Hennon, R&Q
Although a lot has changed in our worlds since R&Q's December 2019 webinar focused on Solving the EU MDR Labeling Puzzle, the general requirements have stayed the same. In this blog post, our knowledgeable EU MDR regulatory experts sat down to provide some updates on a few more...
Read Moreon 15 July 2020 | By Deven Hennon, R&Q
15 July 2020 - R&Q experts discuss "First Do No Harm - The report of the Independent Medicines and Medical Devices Safety Review."
Read Moreon 7 July 2020 | By Stephen Biernacki
In this on-demand webinar originally presented in July 2020, find out how to create detailed, compliant, and business-balanced PMCF plans.
Read Moreon 6 July 2020 | By Deven Hennon, R&Q
R&Q's May 2020 webinar focused on FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for prevention and treatment of COVID-19. In this blog post, our knowledgeable FDA and EU MDR regulatory experts sat down to provide answers to your...
Read Moreon 22 June 2020 | By Susan Farabaugh, RQM+ Consultant
You have been reviewing the 4th revision of the European Commission’s Guidelines on Medical Devices, "MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC" to make sure you are following all requirements to get...
Read Moreon 15 June 2020 | By Deven Hennon, R&Q
R&Q is a Premium Solutions Partner of the Regulatory Affairs Professionals Society (RAPS) and in April, we joined forces to offer up a premium webcast. R&Q Executive Director of Regulatory and Quality Consulting Services, Nancy Morrison, presented PMS Requirements of the EU MDR:...
Read Moreon 8 June 2020 | By Deven Hennon, R&Q
R&Q's April 2020 webinar focused on Structuring Performance Evaluation Reports (PERs) under In Vitro Diagnostic Regulation (IVDR). In this blog post, our knowledgeable IVDR experts sat down to provide answers to your questions from the webinar and we hope that they will shed...
Read Moreon 18 May 2020 | By Deven Hennon, R&Q
As we collectively watch the world struggle to cope with the devastating impacts of COVID-19, the Emergency Use Authorization Act has given the R&Q team opportunities to provide pro bono regulatory guidance to incredible medical device companies that are prioritizing “giving...
Read Moreon 13 May 2020 | By Deven Hennon, R&Q
Tuesday 2 June 2020 — An FDAnews Webinar featuring R&Q
Read Moreon 8 May 2020 | By Stephen Biernacki
On-Demand - A webinar entirely dedicated to case studies.
Read Moreon 8 May 2020 | By RQM+ Subject Matter Experts
Welcome to the Remediation Station! We've got live shows with the experts, case studies, and insights to help you get through remediation successfully.
Read Moreon 1 May 2020 | By Stephen Biernacki
Chatting with Former FDA and Notified Body Representatives
Read Moreon 1 May 2020 | By Deven Snyder
If you were excited when the European Commission finally released four guidance documents covering Clinical Evaluation Equivalence, Clinical Evidence of Legacy Devices, and templates for the Post-market clinical follow-up (PMCF) Evaluation Reports and Plans (MDCG 2020-5-8) last...
Read Moreon 28 April 2020 | By Deven Snyder
R&Q's March 2020 webinar focused on dealing with EU MDR Audit Nonconformances. In this blog post, our knowledgeable EU MDR experts sat down to provide answers to your questions from the webinar and we hope that they will shed some light on similar questions that you may have on...
Read Moreon 27 April 2020 | By Stephen Biernacki
26 May 2020 - Processes, tips, and lessons learned.
Read Moreon 24 April 2020 | By Mark Jordi, Ph.D., RQM+ Principal Advisor
Dynamic mechanical analysis, sometimes abbreviated to DMA, is a workhorse technique used to investigate the various mechanical properties of materials as a function of frequency, temperature, and time. The goal is to ultimately get an in-depth assessment of the stress and strain...
Read Moreon 17 April 2020 | By Deven Snyder
This post is an update to our recent blog post where Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shared her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline. You can read that post here.
Read Moreon 15 April 2020 | By Deven Snyder
At R&Q, we are seeing firsthand how heavily impacted companies of all sizes are by the volatile global markets brought on by the COVID-19 pandemic. To assist our country’s more vulnerable businesses, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed in...
Read Moreon 13 April 2020 | By Deven Snyder
Medical device companies often have a globally distributed workforce which can include remote specification developers and, more likely, manufacturing sites. In China alone, where the virus was first detected, many medical device companies have manufacturing sites, utilize...
Read Moreon 9 April 2020 | By Stephen Biernacki
The current pandemic is challenging for everyone to varying degrees. R&Q has the utmost respect, appreciation, and love for healthcare workers and all frontline workers across the globe. Our mission from the start has been to improve people's lives and our announcement today has...
Read Moreon 6 April 2020 | By Stephen Biernacki
Note: this webcast is now available on demand. R&Q is a Premium Solutions Partner of the Regulatory Affairs Professionals Society (RAPS) and on Wednesday, April 15th, we're joining forces to offer up a premium live webcast. Attendees will earn 1.5 RAC credits and the event is...
Read Moreon 3 April 2020 | By Stephen Biernacki
In February – just before COVID-19 began to seriously impact those of us in the United States – R&Q Executive Director of Regulatory & Quality Consulting Services, Nancy Morrison, presented the webinar PMS Requirements of the EU MDR: Implementation Challenges and Solutions. We...
Read Moreon 1 April 2020 | By Stephen Biernacki
Whether you are interested in improved strategies for completing PERs or effectively completing your first PER, our April 2020 webinar can act as a critical guide.
Read Moreon 19 March 2020 | By Deven Snyder
Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shares her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline: Team NB, the European Association of Notified Bodies (NB) that are active in the medical device...
Read Moreon 18 March 2020 | By Deven Snyder
As most of the world seems to be at a standstill this week, the European Commission published new guidance (MDCG 2020-3) to further define “significant change” requirements under the new Medical Device Regulation (MDR) policies coming our way on May 26, 2020. The highly...
Read Moreon 5 March 2020 | By Stephen Biernacki
Preparing, managing and responding to nonconformances.
Read Moreon 28 February 2020 | By Stephen Biernacki
R&Q's first webinar of 2020 was the first in a two-part series on bringing your medical device to market in the United States. Part one addressed Class I and Class II devices, while part two (TBA in the spring) will cover Class III devices. The questions we received related to...
Read Moreon 24 February 2020 | By Deven Snyder
Check out R&Q experts' European Union Medical Device Regulation (MDR) 2017/745 Health Check List below to determine the areas to focus your resources in the final few months before the May 26, 2020 MDR Date of Application. If you have questions, concerns, or need any help...
Read Moreon 17 February 2020 | By Mark Jordi, Ph.D., RQM+ Principal Advisor
Scanning electron microscopy (SEM) is an advanced analytical tool that vastly outstrips the capabilities of traditional light microscopy. The standard array of magnifying lenses in a compound microscope enables sample magnification by up to 1000x, using visible wavelengths of...
Read Moreon 31 January 2020 | By Stephen Biernacki
Our February 2020 webinar will help you optimize every element of PMS/PMCF as it relates to the EU MDR at your organization.
Read Moreon 31 January 2020 | By Deven Snyder
After four years, many heated debates, several delays, and a few Prime Ministers later, the United Kingdom (U.K.) is officially leaving the European Union (EU) today, January 31, 2020. Well, sort of. Instead of the “hard Brexit” that had been promised and feared in March, April,...
Read Moreon 27 January 2020 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 8 January 2020 | By Stephen Biernacki
Our January 2020 webinar is designed to help you create a comprehensive regulatory strategy that enables you to successfully enter the US market.
Read Moreon 7 January 2020 | By Taryn Meade, RQM+ Director of Biological Evaluation Consulting
The Federal Food, Drug, and Cosmetics Act establishes strict requirements for devices and products marketed to consumers and professionals in the U.S. This includes medical devices, food and pharmaceutical packaging, and cosmetics containers. Before a new product can be...
Read Moreon 6 January 2020 | By Deven Snyder
During a December meeting of the European Union’s Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), European Commissioner for Health and Food Safety, Stella Kyriakides, confirmed that the May 2020 deadline for Medical Device Regulations (MDR) implementation...
Read Moreon 18 December 2019 | By Deven Snyder
The holidays may have just gotten a little happier and a lot brighter for those of us in the medical device industry! Earlier this week, the U.S. House of Representatives passed legislation to repeal the impending and much-criticized Medical Device Tax, a 2.3% excise tax on...
Read Moreon 9 December 2019 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 27 November 2019 | By Nancy Morrison, RQM+
RQM+ clients have one more thing to be thankful for this year as a new Corrigenda to the European Union Medical Device Regulation (MDR) has been issued that extends the due date for Certificates for Class I – reusable surgical instruments – for four years. Check out the newly...
Read Moreon 26 November 2019 | By Deven Snyder
The R&Q offices are buzzing with excitement as the holidays quickly approach! Many of us are preparing to gather with family and friends this week to celebrate Thanksgiving over a warm meal, football on the TV and great conversation with loved ones. As much as we are a company...
Read Moreon 25 November 2019 | By Stephen Biernacki
Regulatory & Quality Solutions (R&Q) is absolutely delighted to announce Ralph Asencio as Vice President of Technical Services! R&Q has plenty to be thankful for in 2019. It's been an incredible year for a multitude of reasons, one of which has been the addition of key technical...
Read Moreon 7 November 2019 | By Deven Snyder
Get ready for an active fourth quarter in the European Medical Device Regulation (MDR) world! We sat down with R&Q's Nancy Morrison, Executive Director of Regulatory and Quality Consulting Services, to get her thoughts on the newly released "Ongoing Guidance development within...
Read Moreon 5 November 2019 | By Deven Snyder
From new software and cybersecurity guidance to updates to existing medical software policies, September was a busy month for FDA guidance releases. During our October webinar on FDA Updates for Medical Device Manufacturers, R&Q experts addressed these changes and what impacts...
Read Moreon 28 October 2019 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 18 October 2019 | By Erin Gontang
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 4 October 2019 | By Nancy Morrison, RQM+
September was an incredible month for us at R&Q. Our thought leaders were out and about at DeviceTalks Minnesota, our own 3-hour CER Virtual Workshop (now available on demand), The MedTech Conference (AdvaMed), and the RAPS Regulatory Convergence. Whew! If you participated in...
Read Moreon 30 September 2019 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 17 September 2019 | By Stephen Biernacki
Our December webinar will help you understand and act on requirements.
Read Moreon 17 September 2019 | By Stephen Biernacki
Our November 2019 webinar looked at how to assess products and more.
Read Moreon 17 September 2019 | By Stephen Biernacki
Our October 2019 webinar highlighted key areas of change related to the FDA.
Read Moreon 11 September 2019 | By Mark Jordi, Ph.D., RQM+ Principal Advisor
The acronym GMP refers to the good manufacturing practices promoted by the U.S. Food and Drug Administration (FDA) under the remit of the FD&C Act; which mandates strict levels of quality assurance at every stage of the pharmaceutical manufacturing chain. Although GMP principles...
Read Moreon 20 August 2019 | By Kevin Rowland, RQM+ Director of R&D
The molecular weight of proteins, natural and synthetic polymers is a clear indicator of product performance and activity. To control product performance across a broad range of applications, the understanding of molecular weight determination is key.
Read Moreon 27 June 2019 | By Stephen Biernacki
While we're in the midst of taking the summer off from webinars (see you in the fall!) and excitedly preparing for our CER Virtual Workshop in September, we did have our most popular and best-reviewed webinar ever in May: Integrating CERs and Post-Market Surveillance. The...
Read Moreon 21 June 2019 | By Mark Jordi, Ph.D., RQM+ Principal Advisor
Polymer molecular weight (MW) is the molecular mass of a polymer chain. While small molecules of the same elemental composition all exhibit the same molecular weight, polymer chains exhibit different characteristics. These chains are compounded from multiple small molecules that...
Read Moreon 18 June 2019 | By Nancy Morrison, RQM+
One of the most rewarding aspects of regulatory work is that no two days are the same. There are always new (and constantly evolving) technologies and regulations to provide fresh opportunities to show your skills. If you’ve been tied up trying to get ready for May 26, 2020 and...
Read Moreon 5 June 2019 | By Allison Komiyama, Ph.D., RAC, RQM+ Vice President, MedTech Innovations
In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of...
Read Moreon 22 May 2019 | By Mark Jordi, Ph.D., RQM+ Principal Advisor
Elemental analysis is a process in analytical chemistry in which a sample of material such as water, minerals and bodily fluid is analyzed to ascertain its elemental composition. Elemental analysis can be qualitative, determining which elements are present or quantitative,...
Read Moreon 9 April 2019 | By Stephen Biernacki
In March R&Q partnered with the Medical Alley Association in Minneapolis and MassMEDIC in Boston to offer industry-leading educational workshops on the EU MDR and CERs. R&Q recruited top industry experts, including representation from notified bodies BSI and GMED North America,...
Read Moreon 8 April 2019 | By Stephen Biernacki
Regulatory & Quality Solutions (R&Q) continues to grow aggressively – all while never sacrificing the high quality of service our clients have come to expect (this is a guiding principle and will never change) – and our latest addition to the team is particularly exciting. R&Q...
Read Moreon 25 March 2019 | By Stephen Biernacki
More companies will require notified body involvement.
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