29
Oct
2001

Bunnell Inc.

0

Company: Bunnell Inc.
Date: 10/29/01
Product: High frequency jet ventilators and accessories for neonatal use

Failure to validate processes that cannot by fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example the compliant handling software program, ultrasonic sealing procedure, leak testing procedure, and injection molding procedure have not been validated. Also, changes made to the ventilator burn-in procedure process have not been validated.

FDA District: Denver District Office

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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