R&Q's Blog

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


ISO 13485:2016 Companion Handbook Now Available


ISO has published a companion handbook to ISO 13485:2016, Medical devices-Quality management systems - Requirements for regulatory purposes. From AAMI:

It provides users with practical guidance and accurate interpretation of the requirements specified in the standard. It offers device manufacturers step-by-step guidance applicable to the all stages of a medical device's life cycle from gathering customer requirements to design and through to post-market surveillance of devices. This go-to resource is ideal for regulatory, compliance, quality management professionals who are committed to implementing and maintaining a quality management system that is effective and meets applicable regulatory requirements.

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.

Webinar Q&A: Risk-Based Approach to ISO 13485:2016


Last month and as part of the R&Q Intelligence Series we conducted the webinar, Risk-Based Approach to ISO 13485:2016: Risk considerations and implementation. Risk considerations and implementation of a risk-based approach in your QMS processes is one of the most significant changes to the current version of ISO 13485. Medical device organizations must define how they manage risk in their processes and how the risk of one process affects other risk aspects of the QMS.

At the end 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.

A Risk-Based Approach to Your QMS Implementation - ISO 13485:2016 and ISO 9001:2015 [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: March 28th, where we'll discuss the Medical Device Single Audit Program (MDSAP).

Vital To-Do for 2017: Prepare for ISO 13485:2016

“Procrastination is the bad habit of putting of until the day after tomorrow what should have been done the day before yesterday.” - Napolean Hill

It's really never too early, especially when it comes to renewing the certifications you need to keep your product on the market. In fact, the time is now to start your transition to ISO 13485:2016. Certification bodies will have difficulty having enough auditors and long wait times are expected. Don’t get caught in that last minute rush to renew certifications.

R&Q’s QMS expert, Mark Swanson, was a member of the ISO working group that revised ISO 13485, so R&Q can bring you detailed information on the intent behind the requirements. R&Q on the whole will ensure you can fully prepare for your certification audit with minimal issues, keeping your product on markets worldwide.

Minnesota Momentum: R&Q Hires Member of ISO Technical Committee 210, Mark Swanson

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory. Welcome, Mark!

Mark's addition firmly establishes R&Q in the Twin Cities and prepares R&Q to handle growth in the region. The hiring also builds upon R&Q's existing technical leadership, increasing company-wide capability. Mark will certainly be seen and heard across Minnesota on behalf of R&Q, starting today at MD&M Minneapolis!

Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE).

Read on as we ask Mark three questions about his work on the ISO Technical Committee and shed light on his background/experience.

10 Tips for Adopting the Updated ISO 13485:2016 Standards: Webinar Slides and Recording

Missed our latest webinar on this year's ISO 13485 changes? Now you can download the slides and recording.

R&Q's Director of Regulatory Affairs Nancy Morrison and Client Solutions Advisor Christine Santagate walked through 10 tips for adopting the latest changes. From conducting a gap assessment and creating a quality plan to modifying procedures/processes and auditing, they communicated industry best practices to help those in the industry confidently take the next steps in their process.

The New ISO 13485 Standards are Here! Sign Up for a Free R&Q Webinar

The world's most well known standards for medical device quality management have been updated for the first time since 2003. Released in March by the International Organization for StandardizationISO 13485 provides the universal requirements for manufacturers and service providers to comply to regulatory requirements. The standards aim to establish consistent processes for medical device design, progression, installation and distribution, focusing on the safety of the total life span of the device.

Register Here

Some of the essential changes:

  • Globally aligning regulatory requirements
  • Applying risk management practices throughout the quality managment system
  • Attention to supplier sourcing and selection
  • Supplemental requirements for design activities, such as validation and verfication
  • More specific requirements for Design and Development, Corrective Action and other applications
  • Required Medical Device File to validate compliance to new standards 

The standards must be adopted by 2019, which could prove to be a difficult task for manufacturers. Commencing adoption sooner rather than later will aid a steady transition, and that's why we're hosting a free webinar.

FDA’s Guidance Document on Voluntary Submission of ISO 13485 3rd Party Audit Reports

I came across an FDA guidance document – not entirely recent; however, I found it very interesting and worth sharing. It is on voluntary submissions of audit reports done by auditing bodies outside of the FDA.

A QMS Outcast: Preventive Action

We in the medical device industry throw the term CAPA around like it's a word that is common-place in our society (though, here in Pittsburgh, you'll get a lot of confused looks if you tell someone you've opened a CAPA as it is a local performing arts school. That's a strange nightmare with future Broadway stars re-enacting a root cause analysis!).

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