Sysmex Corp – code coverage

Company: Sysmex Corp
Date: 01/22/2002
Product name: Clinical laboratory diagnostic devices, including hematology, reticulocyte, urinalysis and coagulation analyzers

Failure to establish and maintain documented procedures to control and verify the design of the device in order to ensure that specified design requirements are met, as specified in 21 CFR 820(a)(1). For example, there were no procedures for review of source codes in design controls for software validation, and there is no assurance that all lines and possibilities in the source codes are executed at least once.

FDA District: Center for Devices and Radiological Health (CDRH)

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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