The EU is now close to release of a revision of the Medical Device Directive (MDD). The full text with change marks is at the link provided. The MDD has expanded clause 12.1 into an (a) and (b) sub-clause with the latter specifically addressing software and the former being the original 12.1. The text of...Read More
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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