Jan

2005

Cincinnati Sub-Zero Products

Company: Cincinnati Sub-Zero Products
Product: Class II hypo/hyperthermic machines
Date: 1/10/05

Your Customer Communication Procedure states the “technical service manager or alternate shall document the analysis and conclusions of inquiry.” The procedure also states that “if no analysis is required, the technical service manager or alternate shall document the reason” and it should be in the _____ computer system. Twenty-one of 21 complaints reviewed have not had this information documented.

FDA District: Cincinnati District Office

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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Amy Sellers

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