Instructor:
John E Lincoln
Product ID: 701087
The U.S. FDA requires an IDE (Investigational Device Exemption) to be developed for any new product that is to be involved in clinical trials. This affects not just FDA Class III PMA devices, but increasingly many FDA Class II devices subject to 510(k) Premarket notification and clearance.
Areas Covered in the seminar:
Who will benefit:
Instructor Profile:
John E. Lincoln, consultant, has successfully designed, written and run all types of qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 27 years of experience, primarily in the medical device industry
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