ISO 14971:2019 – Changes in the Current Version of ISO 14971

The third edition of ISO 14971 was finally released in December 2019 and it replaces ISO 14971:2007. Overall, no tectonic shifts have occurred – the risk management process itself remains largely unchanged. Nonetheless, there are important clarifications and updates in ISO 14971:2019 that you should be aware of. Get up to speed on the changes with our ISO 14971:2019 Risk Management Class. In reviewing the new ISO 14971 standard, pay particular attention to the highlighted sections below. ISO/TR 24971:2020 Is […]

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Yes, You’ve Evaluated Every Risk – But Are You Properly Documenting Medical Device Benefits?

Risk. Risk. Risk. Some days it can feel as though our sole mission as medical device regulatory professionals is to raise red flags about what could go wrong. Without a doubt, safety is where the focus should be. Yet, when ISO 14971 instructs us to reduce risks “as far as possible,” it is easy to lose sight that there is a benefit-risk tradeoff. So while the focus of your job may be on reducing risk, the reason we create medical […]

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FDA Medical Device Cybersecurity: Understanding Your Basic Regulatory Requirements

UPDATED 3/10/2021   This is the second post in a three-part blog series on risk management and cybersecurity. In our first post we review general risk management requirements for cybersecurity.  The final post is a series cybersecurity related documents you should download. A hacker gains access to someone’s insulin pump via their wi-fi connection and then overdoses the patient, killing them. A “made for TV” fantasy? Unfortunately not. In 2019 the FDA identified this very real risk to devices made […]

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6 Medical Device Compliance Issues That Will Demand More of Your Bandwidth in the Next 12 Months

The next 12 months are sure to be a wild ride for medical device RA/QA professionals. There’s a lot going on in the world of regulatory compliance and there is little doubt that your workload is about to increase – you may have seen it happening already. Here’s what we are hearing from our clients about issues they expect will consume more of their precious time this year. 1 – Internal audits and gap assessments The new European medical device […]

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