Daniel Kamm

Background

About Daniel Kamm

Daniel Kamm, P.E. is the Principal Engineer of Kamm & Associates, founded in 1990. He is a Registered Professional Engineer in Illinois and Florida. Life Senior Member, He is an electronics engineer and regulatory affairs executive with over 50 years experience in the medical device business, who specializes in FDA submissions, Good Manufacturing Practices auditing, consulting, and training. He has made over 400 successful 510(k) submissions and has 2 PMA approvals. He also designs medical devices and thus has a unique grasp of the problems and solutions to the GMP problems encountered by the device manufacturer. He has assisted the smallest to the largest device manufacturers on a world-wide basis to become GMP compliant and pass FDA inspection. He has directed R&D, regulatory affairs, and quality assurance efforts in both small and large companies. International experience includes assignments in Canada, China, Finland, France, Germany, Italy, Japan, Korea, Netherlands, and Sweden. Mr. Kamm holds a B.S. in Electrical Engineering from Washington University Specialties: FDA Submissions: 510(K), IDE, PMA, Product Reports. Medical Device License Submissions for CANADA FDA 483 and WARNING LETTER: Strategies and Responses cGMP Compliance Programs: AUDITING - CONSULTING - TRAINING - CERTIFICATION FDA Registration and Listings Official FDA Correspondent and/or Agent for Non-USA firms Validations: Software, Process and Product. Risk and Hazard Analysis