The latest and most up-to-date version of IEC 62304 is the 3rd edition, which was released in June of 2016. The main changes from the 2nd edition include updates to terminology, clarification on risk management processes and requirements, and the addition of a new product lifecycle extension stage.

IEC 62304 is a standard for medical device software development and is widely recognized as one of the most comprehensive and rigorous standards in this area. It covers all aspects of the software development life cycle, from requirements specification to post-market surveillance.

If you’re looking for an organization that can help you comply with IEC 62304, Wi4 Corporation is one of the leading providers in this area.

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