R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Welcome, Jacob Foster: Regulatory and Quality Solutions' New Senior Principal Engineer

Jacob Foster brings 20+ years of medical device and pharmaceutical regulatory, quality, and project management experience to R&Q. He also brings an engaging personality, eager to do more for clients.

Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q) exists to improve people’s lives and bring more safe and effective medical devices to market for medical device and combination product companies. Our results derive from a cohesive, hard-working, entrepreneurial, and supportive culture – a culture in which Jacob Foster effortlessly fits in.

R&Q is truly ecstatic to announce that Jacob Foster has been named Senior Principal Engineer.

An industry veteran of the global pharmaceutical and medical device industries, Foster brings extensive management, project leadership, and hands-on quality systems development experience to R&Q’s rapidly expanding operations team. His years of experience in the ever-changing regulatory environment  - including the upcoming and all-important EU MDR - strengthens R&Q's ability to expertly and efficiently serve clients. Foster has lived through uncertain times in the industry and despite the complexity of changes, has a track record of successfully navigating and deciphering them.

“I met the team at R&Q about three years ago, and became “fast friends” with each and every team member I was introduced to," said Foster. "So when the opportunity arose to join R&Q, it was one of the easiest decisions I have ever had to make. The culture of R&Q and the earnest sincerity to contribute to patient safety and client success is tangible. Who would not want to be a part of that?”

Preparing your CER for MDR [Upcoming Webinar]

The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market for a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices.

R&Q's next Intelligence Series webinar, Preparing your CER for MDR: Gathering Clinical Evidence, will be held on Tuesday, Novemer 28th from 1:00pm - 2:00pm EST.  The presentation slides, webinar recording, and Q&A will be made available to registrants.

Register in seconds at the link below, and read on for full webinar details. We hope you'll join us!

Sign Up

Webinar Q&A: EU MDR / CER Portfolio Planning

In September and as part of the R&Q Intelligence Series, we conducted the webinar, EU MDR / CER Portfolio Planning: Know the essential EU MDR portfolio planning requirementsPortfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules.

At the conclusion of the webinar we answered several questions, and a sampling of those questions and answers is below. To read more about the webinar, read all questions and answers from the session, and gain access to the slides and recording, check out the on-demand webinar.

EU MDR / CER Portfolio Planning: The Essential Requirements [Free Webinar]

What? 

Please join us for September's free R&Q Intelligence Series webinar:
EU MDR / CER Portfolio Planning: Know the essential EU MDR portfolio planning requirements.

The session will take place Tuesday, September 26 from 1:00pm - 2:00pm EST.

 

Register Now

 

Portfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules.

The time to plan is now.

MEDDEV 2.7/1 & CERs: Questions and Answers

Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7/1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision.

Furthermore and once the regulation comes into force, the European Medical Devices Regulation (MDR) will impact CERs as well. It is important to be proactive to ensure CERs will meet your notified body expectations. You must review your clinical strategy carefully.

R&Q recently presented the webinar, MEDDEV 2.7/1 & CERs: Know the changes and what to do. Towards the end of the session we answered several questions, a sample of which are below. To see all questions and answers from the session - along with the slides and recording - check out the on-demand webinar.

Cybersecurity for Medical Devices: Questions and Answers

As the number of network connected medical devices increases, opportunities for improved patient care also increase. As a consequence, the vulnerability to cyber-attacks becomes a greater threat. Medical device cybersecurity threats can be dangerous for providers, networks, and device manufacturers. They can put patient safety at risk and/or create a breach of data. The FDA encourages manufacturers to consider potential cybersecurity risks and vulnerabilities “throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device.”

R&Q recently presented the webinar, Cybersecurity: Regulatory and quality ramifications. During the session we answered several of your questions, a sample of which are below. To see all of the questions and answers from the session, along with the slides and recording, check out the on-demand webinar.

EU MDR: Your Questions, Our Answers

On May 5, 2017 the EU MDR (Medical Device Regulation) was published in the EU Official Journal. This date starts the three-year mandatory transition period where the MDR will replace the MDD (Medical Device Directive). The expanded scope of the MDR combined with the time frames for compliance is compelling medical device companies to focus significant attention on transition strategies and will require substantial hands-on work.

R&Q recently presented the webinar, EU MDR: Assessing the Impact and Next Steps. During the session we answered several of your questions, a sample of which are below. To see all of the questions and answers from the session, along with the slides and recording, check out the on-demand webinar.

RESOURCE: The MDR and IVDR Have Been Published! See Our Table of Key Dates

Publication in the Official Journal of the European Journal on May 5, 2017 means the regulations will enter into force on May 26, 2017, twenty days after publication. We will have a three-year transition period for the MDR and a five-year transition period for the IVDR. Products can be issued a certificate under the MDD with a full five-year expiry for the first two years of the transition period but should comply with all other aspects of the MDR in May, 2020. Since most IVD products are currently on the market as a self-certified they will require certificates by the end of the five-year transition period where most products now require Notified Body involvement.  

EU MDR and Clinical Evidence: What You Need to Know

THE SKINNY: The Council of the European Union adopted the proposed new European Medical Device Regulation (EU MDR) in March 2017 and passed by Parliament in April 2017. It is expected to be published in the Official Journal of the European Union in the upcoming weeks, making the application date mid-2020. The EU MDR will replace the Medical Device Directive (Council Directive 93/42/EEC) and the Active Implantable Medical Device Directive (Council Directive 90/385/EEC). Among the vast changes occurring with this transition from directive to regulation are the new requirements surrounding clinical evidence. If you found the clinical portion of your technical documentation to be challenging in the past, you need to prepare for some additional hurdles.

 

~ Note: This post is just a taste of the detail we'll explore during our R&Q Intelligence Series webinar on EU MDR April 25th at 1:00pm EST. All registrants will have access to the slides and recording from the session.

Register Now

 

EU MDR: Assessing the Impact and Next Steps [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: May 23rd, where discuss MEDDEV 2.7.1 & CERs.

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