The attached are slides from a presentation given by Stewart Crumpler of FDA CDRH regarding comments received on the draft “General Principles of Software Validation Guidance”. This presentation was given in July 1999 at the Biofocus conference. The intent is to resolve comments and issue a final guidance in early 2001.
Being Agile & Yet Compliant (Public)
Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!
3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.
Lead Instructor: Mike Russell
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IEC 62304 and other emerging standards for Medical Device and HealthIT Software
Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.
3-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Brian Pate
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Medical Device Cybersecurity (Public or Private)
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2-days onsite with group exercises, quizzes, examples, Q&A.
Instructor: Dr Peter Rech, 2nd instructor (optional)
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