WalterGraphtek Digital electroencephalographydevs

Walter Graphtek GMBH 4/29/97 Digital electroencephalography devices

1. Failure to assure that specification changes shall be subject to controls as stringent as those applied to the original device, as required by 21 CFR 820.100(a)(2). For example, there are no documented procedures for the initiation, verification, validation, approval, implementation and documentation of device hardware and software changes.

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

Being Agile & Yet Compliant

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Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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