Evaluating and Accepting Medical Device and IVD Residual Risk

Medical device manufacturers and regulators generally have different goals, but one thing they have in common is a desire to make sure devices are safe and effective. To achieve that, regulatory managers often spend a substantial amount of time analyzing, evaluating, and controlling all manner of risks. Of course, risk can never be entirely eliminated, and despite your best efforts at controlling them, there will always be what is called “residual risk.” The question for many is how residual risk […]

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ISO 14971 Certification Plus 5 More Medical Device Risk Management Myths

ISO 14971 has been the de facto international standard for medical device risk management for more than 20 years. If you want to sell your devices in the US or Europe, the standard will become an absolute necessity in your quest to obtain FDA clearance / approval for your device or CE Marking certification under the EU MDR or IVDR. ISO 14971 was initially known as EN1441 and was introduced in 1997. Soon after (in 1998), the first version of […]

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Overview of Medical Device Cybersecurity Standards and Guidance Documents

UPDATED 2/2/2022 This is the final post post in a three-part blog series on risk management and cybersecurity. In our first post we review general risk management requirements for cybersecurity.  In our second post we discuss cybersecurity requirements for software and SaMD. If you are fairly new to risk management and cybersecurity compliance, you probably have noticed that there is a mind-boggling array of guidance and regulations online. Separating the “must have” from the “nice to have” can be as […]

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Risk Management Review, Reporting and Postmarket Planning

As part of the risk review process, you’ll need to assess your risk management activities against the risk management plan on three levels: 1 – Has the plan been implemented appropriately? 2 – Is the overall residual risk acceptable? 3 – Are production and post-production information collection methods implemented? The summation of answers to these questions becomes your risk management report, which is part of your larger risk management file. The report documents the conduct and results of your risk […]

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