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Medical Device Reporting regulation

medical regulation

scientific misconduct

United Kingdom healthcare expense reimbursement

medical lexicon

Safe Medical Devices Act of 1990

medical device reporting

medical device auditing

medical device safety

medical device testing

medical device clinical research

medical device premarket approval

medical device sterility

510(k) document

medical device product development

medical device hazard analysis

medical device product improvement

medical device sterilization

medical device process validation

medical device mechanical stress analysis

medical device manufacturing

medical device design

medical device

Expert in Product Development, Product Safety, Product Testing, Claims Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. See full profile

Arizona (AZ), USA

Expert in 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 ... See full profile

Minnesota (MN), USA

Expert in Medical Device Technology Coverage and Reimbursement, Clinical Trial Design, Protocol Development
For thirteen years, Expert was National Medical Director of Coverage and Reimbursement for Aetna and Health Net. In those roles he was responsible for developing Medical Policies stating the coverage and reimbursement decisions of the company ... See full profile

Connecticut (CT), 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 Professional QA & Regulatory Compliance for Medical Devices, Plastics Process Qualification
Expert has over 30 years of experience as a quality improvement professional, providing technical and managerial quality systems management. His base is a select group of processes within which we maintain current knowledge and process engineering skills. See full profile

North Carolina (NC), USA

Expert in Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due ... See full profile

Virginia (VA), 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 Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. See full profile

Oklahoma (OK), 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 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 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 FDA Regulations for Medical Devices, QSR, Risk Management, Medical Device Design
Expert (MSEE) has designed medical devices and equipment for over 20 years. He helped companies develop medical devices, obtain 510(k) clearances, and comply with QSR (cGMP) for over 15 years. Expert has expertise in Risk Management per ISO ... See full profile

California (CA), 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 International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. See full profile

Wisconsin (WI), 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 ... See full profile

California (CA), 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 Quality Assurance Engineering
Expert has over 15 years of experience with quality assurance. He provided Quality Assurance support to insure timely and cost effective: systemic, design, component and product compliance. His activities included supporting: New Product Development, ... See full profile

Nevada (NV), USA

Expert in Radiation Physics
As a Certified Health Physicist and an Radiation Safety Officer, Expert has had extensive experience with dosimetry methods for both occupational radiation workers as well as for patients undergoing medical procedures and research protocols. See full profile

Missouri (MO), USA

Expert in EMC/EMI, RF/Microwave, Hardware, Firmware, Product Development
Expert has experience in medical imaging product design and certification regarding FCC, CE, UL, and the FDA. He is familiar with the technical file and the 510K preparations regarding the medical regulation requirements and the requirements ... See full profile

Arizona (AZ), USA

Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into ... See full profile

New Jersey (NJ), USA

Expert in Telemedicine Configuration Testing and PACS Devices, Software QA, FDA Warning Letters, etc.
A nationally recognized expert in these areas, Expert has been dedicated to this field since 1986, when the FDA wrote their initial software guidance document. She has been responsible for compliance turn-around and start-up companies initial ... See full profile

Maryland (MD), USA

Expert in Medical Device Sterilization
Expert is an expert in medical device sterilization. He has advanced technical knowledge in all phases of sterilization, including work with heat, chemical, and irradiation sterilization processes. He is especially adept with the irradiation ... See full profile

South Carolina (SC), USA

Expert in Pharmaceutical Product Development and Good Manufacturing Practices (cGMP, IQ/OQ, CMC, FDA, etc.)
Expert is a consultant to the pharmaceutical and allied industries. His background includes 28 years with DuPont and DuPont Merck in a variety of positions. In his last assignment at DuPont Merck, he was Senior Director of Technology and Engineering in ... See full profile

New Mexico (NM), USA