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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Case Study: Assembling a Comprehensive Risk Management Approach

Our customer, like many medical device manufacturers, had numerous risk management activities occurring in isolation. Risk management was addressed in design, manufacturing, validation, CAPA, complaints, and other areas, but there was no comprehensive process that served the business or could be articulated to an auditor. In addition, the company’s risk management files were static – the company was not updating the files with post-production, post-market, and other relevant data. Through a combination of training and coaching, our customer’s in-house team […]

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