Is my software SaMD?
As health care advances, software has become integrated widely into digital ecosystems that serve both medical and non-medical purposes. Our…
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MDSAP – When to join the program
Based on ISO 13485:2016, MDSAP (Medical Device Single Audit Program) is an audit program that allows for a single regulatory…
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5 learnings from FDA’s new Biocompatibility guidance
In October last year, the FDA published draft guidance regarding the biocompatibility of certain devices that contact intact skin. Our…
Congenius
Ethics, Expectations & Education: What lies ahead for AI in medical devices?
Artificial Intelligence is changing the world. In a MedTech context, it enables a small team to affect many lives. To…
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The impact of Artificial Intelligence on the medical device industry
The responsible implementation of Artificial Intelligence within MedTech will transform the efficiency of the industry. But which areas within medical…
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