Derek has spent the past 25 years in various operations roles within the Cardiovascular and Orthopedic medical device industries. His expertise ranges from class II instrumentation to class III implantable devices. He specializes in overall operations strategic planning, product and process development, new product introduction, manufacturing optimization, and establishing core business systems for achieving success.
Walt is an ASQ certified Quality Engineer with over 24 years in medical device Quality Assurance and Regulatory Affairs. Specific expertise in establishing robust systems for production controls, design controls, supplier controls, software/process validation, document controls, corrective/preventive action, and complaint handling. Technical lead for FDA quality system regulation, device tracking, universal device identification, ISO 13485:2016 implementation, MDSAP audit preparation, EU Medical Device Directive/Regulation, EU Animal Origin Regulation, Canadian Medical Device Regulation, Risk Management per ISO 14971, Usability Engineering per EN-62366 and preparation of clinical evaluation reports.
John is a recognized expert in cardiovascular devices and spent 7 years at the FDA, where he was responsible for a team that approved cardiovascular medical devices. In industry, he has successfully managed the process of obtaining pre-market approvals for 6 heart valves, including both tissue and mechanical valves. He has also led research and development, regulatory and quality assurance teams at Baxter International Inc., Edwards Lifesciences Corporation and On-X Life Technologies, Inc. John has authored over 25 scientific papers and is the named inventor on 3 US patents. He currently consults in the area of cardiovascular devices particularly for regulatory and clinical research issues, and is a member of the Board of Directors of Aortech International PLC that is developing a flexible leaflet polymeric heart valve.
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