No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments combine a robust cyber security post-market release plan with software applications to support data safety along with...
Ensuring Compliance with New FDA Guidance on Software Documentation & Cybersecurity
New guidance from the FDA replaces similar, but now obsolete, guidance. Some of the guidance was issued in response to the PATCH Act, which is a 2022 amendment to the Food, Drug and Cosmetics Act of 1938 that also pertains to medical device cybersecurity. It includes...
Artificial Intelligence (AI), General Data Protection Regulation (GDPR) and Cybersecurity: 10 Misconceptions About Medical Device Software
Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers must often face a regulatory framework which does not evolve at the same speed. Regulation for medical devices is restrictive, since it needs to guarantee the safety...