UPDATED 3/10/2021 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 […]

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 […]

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 […]