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 by the European Medical Devices Directive (MDD 93/42/EEC) and the EU Medical Device Regulation (MDR 2017/745).…

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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 is viewed to have 100% probability of failure when it does occur. Therefore, this makes software rightfully subject to risk management oversight, including special considerations for software-controlled medical devices.

In this post, we’ll cover the basics of risk management for embedded software or stand-alone Software as a Medical Device (SaMD), so you have an understanding of what is required before, during, and after coding.…

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