Recipient: Ronald G. Crystal M.D.
Product: Investigational biologic products
Date: 9/23/02
Subject _____ was enrolled in the study without Computerized Tomography (CT) documentation of the number of _____ present at the time of enrollment. Section 3.2 of the protocol requires that the subject have two or more _____ detected by CT scan.
Issuer: Center for Biologics Evaluation and Research (CBER)
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
Next public offerings:
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.
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Next public offering: TBD
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Registration Link:
TBD
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)
Next public offering: TBD
