Separation Technology Centrifuges

Separation Technology 3/7/97 Centrifuges

4. Failure to document, review, approve, and validate changes to components, finished devices, labeling, packaging or manufacturing process specifications [21 CFR 820.100(b)(1),(2) & (3)], e.g., there is no documentation of the prior approval of the software specification change initiated 1/24/97 that was an attempt to correct the failures described above. Also, there is no change validation to assure the software modifications will correct the failure mode.

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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.