Multimedi Medical Therapac-Plus/Compute-Rx-Plan SW

Multimedia Medical Systems 3/18/97 Therapac-Plus and Compute-Rx-Plan Software

2. Failure to have approved, dated, and signed Device Master Records for Therpac-Plus Software and related Standard Operating Procedures (SOP) 100 through 133 [21 CFR 820.181].

3. Failure to establish written procedures for the manufacturing and processing of the finished device [21 CFR 820.160]. There is no written procedure and documentation to show that the functionality test had been performed for Therpac-Plus Software Versions V6.409106, V6.409166, V6.409266, V6.411226, V6.411196 and V6.401247, prior to release.

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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