Jan

1998

Nikkiso Co. Ltd. Hemodialyzers

Nikkiso Co. Ltd. 1/27/98 Hemodialyzers

2. Failure to validate computer software for its intended use according to an established protocol when software is used as part of production or the quality system, as required by 21 CFR 820.75(j). For example, the software used to perform _____ has not been validated. This software is part of the quality system and controls the _____ Your management indicated to the investigator that its personnel did not have the knowledge to validate or test the software and would have to be trained in the area.

About the author

Amy Sellers

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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Nikkiso Co. Ltd. Hemodialyzers

Amy Sellers

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