09
Mar
1999

Urometrics Penile tumescence monitors

0

Urometrics 9-March-99 Penile tumescence monitors

1. Failure to establish and maintain procedures for the identification, documentation, validation, or appropriate verification, review and approval of design changes before their implementation as required by 21 CFR 820.30(i) in that there is no data to show that the NEVA program version 2.2.1 (revised 1/20/99) was validated or verified. The NEVA Program Released Software Description for version 2.2.1 references testing that was performed on earlier versions of the software rather than the final version.

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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