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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FDA and EU Risk Requirements for Medical Device Software & SaMD

In our first post we talked about international risk management standards and guidance applicable to medical device software, including the ISO 14971 and IEC 62304 standards. In this post we will discuss specific compliance requirements in the US and Europe for medical device software paired with hardware, and stand-alone Software as a Medical Device (SaMD). Requirements for software risk management in Europe ISO 14971 and IEC 62304 are international standards intended to help you meet regional requirements, such as those imposed […]

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Overview of Risk Management for Medical Device Software & SaMD

UPDATED 3/10/2021 This is the first in a three-part blog series on risk management and cybersecurity. In our next post we take a look at Cybersecurity requirements for software and SaMD and in the final post, key documents you should download. Software itself is not risky. Nobody gets directly injured by bad code or a poorly designed UI and, unlike hardware, software does not fail randomly. That being said, software can definitely expose someone to a hazardous situation because software […]

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