B. Braun Medical Inc

Company: B. Braun Medical Inc.
Date: 9/17/01
Product: Disposable IV sets

Failure to validate computer software used to (1) control the Eto sterilization process, for example, _____ cycles, and (2) control the _____ _____) employed in the manufacture of disposable IV sets, to ensure the software will perform for its intended use. 21 CFR 820.70(i).

FDA District: Philadelphia

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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