26
Nov
1997

Purepac Pharmaceutical Co.

0

3) There are insufficient controls in place to ensure the integrity of calculated data generated by the _____ software in the Quality Control Laboratory, in that:.

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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IEC 62366 Usability Process and Documentation

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