May 1-3, 2017 • San Diego, California
Robert Packard is a regulatory and quality expert with 20 years experience developing products and managing projects in the medical device, biotechnology, and pharmaceutical industries. He is currently a full-time consultant helping companies with regulatory submissions for high-risk medical devices, in vitro diagnostics (IVD) and drug/device combination products. He’s handled Canadian Medical Device License Applications, Design Dossiers for CE Marking, and US FDA 510(k) submissions. In addition, he works with clinical experts for PMA submissions for Class 3 device submissions in the U.S.
Robert’s background in the medical device field includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, quality assurance, and fund-raising. An experienced public speaker and trainer, Robert is known for his ability to explain complex systems.