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      • And more…
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      • Quality management system as a service
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      • Software (IEC 62304, FDA)
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      • Performance evaluation of IVDs
      • Electrical Safety & IEC 60601
      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
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May 9, 2023


Develop software components compliant with IEC 62304 and FDA

By Prof. Dr. Christian JohnerMay 9, 2023Leave a comment

Medical software manufacturers must meet the legal requirements for software components in order to “approve” their devices. This article presents these requirements and gives seven tips on how to fulfill them quickly and easily.

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