Gary Mocnik

Gary S. Mocnik has regulatory, quality, and R&D experience in diverse medical device product lines and technical disciplines. His 30-plus years of regulatory experience includes preparation of large numbers of presubmission meeting requests, 510(k)s, IDEs and PMAs as well as validation and verification planning for new facilities and new manufacturing processes, software, material characterization and biocompatibility, and sterility and package integrity. Mr. Mocnik develops complete Quality Systems compliant with FDA QSR, CMD, and ISO 13485 requirements, implements Risk Management processes to assure compliance with ISO 14971 and establishes documentation systems and procedures that meet or exceed QSR/GLP requirements as well as ISO 13485 compliance and documentation for CE mark. He develops documentation to support CE Marking of medical devices under the MDD and the new MDR that include preparation of Essential Requirements checklists, Technical Files, and Clinical Evaluation Reports based on MEDDEV 2.7.2.