FDA submitted MDDS quality system proposal

A proposal for a guidance document on “Applying the Quality System to Medical Device Data Systems” has been submitted to AAMI by the FDA. The work is expected to be done by the AAMI software committee and the AAMI Quality Management committee.

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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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