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Safe Medical Devices Act of 1990

FDA medical device regulation

medical lexicon

medical device liability

medical device inspection

Medical Device Reporting regulation

medical device auditing

medical device safety

medical device testing

medical device clinical research

medical device hazard analysis

medical device manufacturing quality control

medical device manufacturing

medical device

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 ... See full profile

Illinois (IL), 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 ... See full profile

Florida (FL), USA

Expert in FDA Medical Device Quality Systems, Governmental Registration Process, International Business, GMP
As an ex-FDA official for over 21 years (not only as a experienced investigator/analyst, but also when he acted as field and HQ compliance officers during details to these offices), Expert is highly familiar with FDA compliance. He retains this knowledge ... See full profile

Pennsylvania (PA), USA

Expert in FDA Medical Device Regulation, Expert Testimony
Expert initiately was a FDA field office investigator (drug manufacturing specialist) and compliance officer in the then FDA Bureau of Drugs. During his 17-year career in the FDA Center for Devices and Radiological Health Expert helped to initiate ... See full profile

North Carolina (NC), USA

Expert in FDA Regulations, Labeling and Compliance; Medical Devices, Medical Products Liability
Expert has over 35 years medical device industry experience actively involved in the design, development, manufacture, FDA regulation compliance, labeling, and quality control of medical devices. His expertise includes implementation of corporate ... See full profile

Minnesota (MN), USA

Expert in Electrical and Biomedical Engineering, Patent Analysis
Expert is an expert in medical implants, devices and instrumentation; electrical and biomedical engineering; hospital x-ray and power systems; electrical power systems; electrical fire investigation; product safety and design deficiencies; ... See full profile

Illinois (IL), USA

Expert in Medical Device Accidents, Surgical Fires, Oxygen Safety, Medical Gas Piping, Failure Analysis
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 user. See full profile

Pennsylvania (PA), USA

Expert in Medical Devices and Diagnostics; Life Sciences Products Development, Manufacturing, Marketing
Expert has been the CEO of 6 medical device companies in three countries - 3 public, 3 private, and has been a member of the Board of Directors of seven companies. He is an expert in all areas of general and specific management of a medical device or ... See full profile

Minnesota (MN), USA

Expert in Medical Device Product Commercialization from R&D to Manufacturing, Regulatory and Clinical Trials
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 ... See full profile

California (CA), USA

Expert in Healthcare Consulting: Strategic Planning, Product Development, and Product Launch
Expert has been providing expert strategic and operational advisory services to healthcare investors and development stage healthcare companies for nearly 10 years. He has been involved in direct healthcare management for over 15 years, and ... See full profile

Massachusetts (MA), USA

Expert in GMPs for Drugs, Devices, Biologics
The primary focus of Expert's career has been to establish documentation systems that support the quality assurance requirements of GMP and ISO regulations for product development and commercial manufacturing. See full profile

Minnesota (MN), USA

Expert in FDA Regulatory Consultant for Medical Devices, Cosmetics, and OTC Drugs
Expert is a renowned authority in the cosmetic, OTC drug and medical device industries. He has had over 40 years of experience dealing with regulatory, scientific, and technical issues for FDA regulated industries. He served as Senior Vice ... See full profile

Maryland (MD), 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 ... See full profile

Minnesota (MN), USA

Expert in Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product ... See full profile

New Jersey (NJ), USA

Expert in Medical Device Technology, Design and Manufacturing
Expert is a seasoned engineer with over 20 years of expertise in all aspects of medical device research, product and process development. His major areas of expertise include minimally invasive treatments of vascular disease as well as laparascopic and ... See full profile

California (CA), USA

Expert in Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device ... See full profile

Minnesota (MN), USA

Expert in Medical Device Software, Medical Device Software Engineering, FDA Compliance
Expert has wide range of extensive hands on experience developing and manufacturing medical devices. Over the last twenty plus years he has successfully deployed several medical devices in the cardiovascular, opthalmic, and diagnostic industries. See full profile

California (CA), USA

Expert in Oxygen Therapy & Conservation, Biofeedback, Clinical Management Design, Electronics, & Prototyping
Expert has extensive clinical experience in asthma management and served on the ATS Standards Committee for COPD (Chronic Obstructive Pulmonary Disease) published in 1995. He developed an asthma clinical guidance system, developed three ... See full profile

California (CA), USA

Expert in Biomedical Device Engineering
Biomedical product development; medical device product development; new product development. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. See full profile

South Africa

Expert in Biomedical Engineering, Manufacturing Engineering, R&D
Expert has over 20 years of experience in the research and development of medical devices for: electrodes for transcutaneous sensing and stimulation (EKG, EEG, EMG, TENS, defibrillation, pacing); respiratory therapy, specifically ... See full profile

California (CA), USA