Nov

1998

Ultramedic Ltd Infusion Pump Analyzers

Ultramedic Ltd. 11/25/98 Infusion Pump Analyzers

6. Failure to have an established protocol to validate computer software for its intended use when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, there is no validation protocol for the validation study performed on the software of the IDA-4.

In addition, you need to reevaluate and modify the entire “B4 Design Control” procedure to include all elements of 21 CFR 820.30, Design Controls.

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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Ultramedic Ltd Infusion Pump Analyzers

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