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Expert ID: 721780 New Jersey, USA

Expert 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…

Expert ID: 729827 Pennsylvania, USA

Expert in Medical Device Accidents, Surgical Fires, Oxygen Safety, Medical Gas Piping, Failure Analysis

Eng. Expert has been conducting medical device accident investigations for 25 years and product failure analysis for more than 30 years. These failures sometimes involve the actual failure of a metal, plastic, or glass part or a failure of the…

Expert ID: 729566 Illinois, USA

Expert in Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals

Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…

Expert ID: 728303 California, USA

Expert in Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A

Expert has been the CEO or chairman of seven medical device companies in four countries - four public, three private, and has been a member of the Board of Directors of 10 companies. He is an expert in areas of…

Expert ID: 728193 California, USA

Expert in Medical Devices

Expert is a medical device consultant and executive with more than 20 years experience in the medical device industry. His expertise spans all aspects of medical device commercialization, from medical device product development to medical device manufacturing and quality control;…

Expert ID: 725331 California, USA

Expert in Medical Device Regulatory Submissions

She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…

Expert ID: 725163 Florida, USA

Expert in Medical Device Regulatory Support, Medical Device Registration, etc.

Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…

Expert ID: 713709 Illinois, USA

Expert in Electrical and Biomedical Engineering, Patent Analysis, Medical Devices, Electrical Trauma

Expert is an expert in electrical fire investigation; patent infringement and analysis; devices and instrumentation; electrical and medical device testing including artificial cardiac pacemakers; industrial accidents; electrical power systems; medical implants; sports injuries; product safety and design deficiencies; electrical and…

Expert ID: 713381 Minnesota, USA

Expert in Medical Technology

A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…

Expert ID: 730210 Alabama, USA

Expert in Construction Safety

Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…

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