EU Medical Device Software Regulation Proposal

A presentation of a proposal for EU software regulation at the ISPRA meeting on Medical Device Software May 13, 2003, is at the link provided. Some of the suggestions are based on FDA guidance documents. ISPRA Meeting on SW

This presentation was provided by Poul Schmidt-Andersen of Copenhagen Medical Devices, which is an affiliate of SoftwareCPR. Poul was the founder of the Danish Medical Devices Certification Organization.

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