Innosan S.r.l.

Failure to document approval of all documents established to meet the requirements of part 820, including the date and signature of the individual(s) approving the document, as required by 21 CFR 820.40(a). For example, the device master record was not signed or dated to indicate approval, and the master and working copies of Software for EPROM used in the _____ were not signed and dated as approved.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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