EU MDR CER and EU IVDR PER for Software:
Understanding MDCG 2020-1

The EU Medical Device Regulation (MDR 2017/745) and EU In Vitro Diagnostic Regulation (IVDR 2017/746) put forward a multitude of challenges, chief among them the process of clinical evaluation. For medical device and IVD companies making products that incorporate software, the question of how much clinical evidence to gather can be perplexing. Rest assured that you are not the only one scratching your head. Many are apprehensive about how Notified Bodies will evaluate clinical evaluation reports (CER) or IVD performance […]

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Overview of Medical Device Cybersecurity Standards and Guidance Documents

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 […]

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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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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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