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Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA devices…
Medical Device Design, Simulation and Development
Expert has 25 years of industrial experience in medical devices, consumer products, automotive, robotics, cutting tools and machine tools. He has helped companies to launch 200+ products, published several papers, patents, and chapters in books. His expertise is in medical…
Interventional Pain and Spine Medicine
Expert is an interventional pain and spine physician specialist. Board certified medical professional who maintains composure and focus even in the most difficult and stressful circumstances. Board certified by the American Board of Anesthesiology. Board eligible in pain medicine and…
Biotech/Pharma; Marketing Rare Disease and Specialty Products
After graduating with a Master in Biotechnology and Business Administration and a career in molecular diagnostics and medical devices, Expert redirected his marketing career in Biopharma 12 years ago. He has been driving the global marketing strategy of drugs in…
Biocompatibility Testing and Biomaterials for Medical Devices
Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing Strategy for the pre-clinical evaluation / toxicity testing of an…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Piezoelectrics, Sensors, and Embedded Systems
Expert has worked with piezoelectric materials, BAW & SAW devices, their packaging, and the associated RF electronics from tens of MHz to over 1,500 MHz throughout his career. Expert's efforts have ranged from Design Engineer to Senior Management. As CTO…
Business Optimization, Engineering, Analytical Rigor, Technical Expertise, Due Diligence, Critical Business Analysis to Develop/Implement Change for Profitable Growth
We fuse business optimization, engineering expertise, analytical rigor, and technical expertise to help companies perform due diligence, critical business analysis and design/implement continuous improvement programs to achieve profitable growth. Our firm provides expertise in commercial development, new product development, sourcing,…
Medical Device Business Development, Clinical Trials and Regulatory Strategy, Cardiology, Cardiac Electrophysiology
As a board certified electrophysiologist, Expert has extensive experience implanting and evaluating pacemakers. In addition, she was responsible for regulating pacemakers while at the FDA. Several of her publications are in the area of pacemakers. She is a board certified…
Medical Device Engineering
He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…