MDCG 2019-11 for IVD Software: Qualification and Classification Under the IVDR
MDCG 2019-11 is the guidance that decides two things about a piece of software: whether it is a device at all, and if so, which…
MD Regulatory Blog
Software Medical Device
Software Medical Device
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Software Bill of Materials (SBOM) for Medical Devices: IEC 62304 and FDA Guide
An SBOM for medical device software is no longer a nice-to-have: for any device that meets the FDA’s definition of a cyber device, a machine-readable…
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IEC 62304 Software Verification and Validation: Requirements by Safety Class
The title of this article reflects how the industry talks, not how the standards define the terms. IEC 62304 software verification validation is the search…
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Software as a Medical Device (SaMD): Classification, Requirements and Regulatory Pathway
Software as a Medical Device is defined by the IMDRF as software intended for one or more medical purposes that performs those purposes without being…
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Medical Device Cybersecurity Testing: Methods, Requirements and Regulatory Compliance
Cybersecurity testing for medical devices has moved from recommended practice to submission requirement. The FDA expects security testing documentation in the premarket submission, and MDCG…
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IEC 81001-5-1: The Complete Guide to Cybersecurity for Health Software
IEC 81001-5-1 cybersecurity for health software has become one of the most referenced standards in the medical device and digital health regulatory landscape. As connected…
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SOUP Management Under IEC 62304: A Complete Guide for Medical Device Software
SOUP management under IEC 62304 is one of the most underestimated — and most frequently audited — aspects of medical device software compliance. Almost every…
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IEC 62304: The Complete Guide to the Medical Device Software Standard
IEC 62304 defines the life cycle processes for medical device software. It is the standard a Notified Body reaches for first when it opens a…
