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Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt
Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes,…
wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
Medical Device and Product Development Expert
Expert is a seasoned Engineering Leader with over 20 years of experience in Medical Devices, including Product Development and Product Management. He set up the Global Technology Centre for TE Connectivity and Medtronic in India and has established a Catheter…
Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
Whole Slide Imaging (WSI), Digital Pathology, and Technical Domains
Expert started in the field of WSI -- whole slide imaging -- when he joined a biosystems company in 2013 as a systems engineer. At that time, the specific imaging business unit he joined was a new acquisition, This technology…
Cardiothoracic and Vascular Surgery, Reimbursement, Clinical Trial Design, Litigation
Clinical Associate Professor of Surgery at a major university and Director of Cardiothoracic-Vascular Surgery Research at a research institute. He is triple board certified in Cardiothoracic, Vascular, and General Surgery. Expert maintains an active clinical research department and has over…
Scientific, Clinical, Medical, and Regulatory Affairs
Expert is a senior executive and a global biomedical leader with expertise in all facets of basic, pre-clinical, clinical research, and regulatory science for drug, biologic, therapy, vaccine, and medical device development. Expert is a leader in strategic planning and…
Orthopedic Surgery and Orthopedic Device Regulation
Expert did his undergraduate and medical school at the University of Michigan, an Alpha Omega scholar. His internship and residency were at the University of California at Davis, where he was an outstanding resident of the year on two occasions.…
RoHS market entry requirements for markets such as EU, CE Marking, ISO 12100
Compliance engineer with over 25 years experience with domestic and internal safety standards with a desire to assist customers in balancing the market entry requirements with their internal quality and risk assessment goals
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…