Diagnostic Specialties Microplate processor

Diagnostic Specialties 2/10/97Microplate processor

5. Your firm failed to qualify the [purged text] microplate processing instrument, as well as, the [purged word] Control Software and the [purged text] Software, for their intended use.

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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IEC 62304 and other Emerging Standards Impacting Medical Device Software

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IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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