Nov

1997

Zoll Medical Corporation

Failure to review, evaluate and investigate complaints involving the possible failure of a device to meet any of its performance specifications; failure to thoroughly evaluate and investigate complaints; and failure to validate software used in tracking and trending service and complaints.

4. Failure to validate software used in tracking and trending service and complaints. For example, the _____ and _____ software packages that are used in tracking and trending service complaints have not been validated.

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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Zoll Medical Corporation

Amy Sellers

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