ISO/TR 20416: Best Practices for Medical Device Postmarket Surveillance

How do I define a PMS objective? What postmarket data needs to be collected? How do I analyze it? What’s the connection to other QMS processes such as risk management? As many QA/RA practitioners know all too well, these questions are not well addressed in ISO 13485:2016 and ISO 14971:2019. The goal of this technical report (it’s not a full standard) is to share best practices on how to interpret the general postmarket requirements of the European Medical Device Regulation […]

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Overview of Medical Device Cybersecurity Standards and Guidance Documents

If you are fairly new to cybersecurity compliance and have done some research online, you probably quickly noticed that there is a mind-boggling array of overlapping guidance and regulations. Deciphering their relevance to your device can be as confusing as the topic itself. Yet, making sense of your cybersecurity risk obligations starts with understanding which of these documents are “nice to have” versus “need to have.” To help you better understand the cybersecurity compliance landscape, we have created a list […]

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MDCG 2020-5 Gives Unequivocal Guidance on Medical Device Equivalence Under the EU MDR

If your medical device clinical evaluation relies on a comparison to an “equivalent” device, you may be wondering if your Notified Body would view your analysis as a true “apples to apples” comparison. Although the word “equivalent” seems clear, few words have created more angst in the context of EU Medical Device Regulation (EU MDR). What exactly does “equivalent” mean? Does it mean “exactly the same” or more like “very similar”? The answer depends on whom you ask. But before […]

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Understanding EU MDR Clinical Evidence Required for “Legacy” Medical Devices as Outlined in MDCG 2020-6

Ever since the release of MEDDEV 2.7-1 rev 4 in 2016 and the publication of the European Medical Device Regulation (EU MDR) in 2017, manufacturers have been coming to grips with the realization that their existing clinical data was not going to cut it in the new EU MDR paradigm. As existing Medical Device Directive (MDD) certificates begin to expire, many manufacturers of legacy medical devices are understandably nervous about how their existing clinical evidence (clinical data + clinical evaluation […]

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