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medical device registration


510(k) document


'510k' Experts

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Expert in Medical Device, Biotech, Pharma R&D, Tech Transfer, Mfg, Compliance, IP Valuation, Process Improvement
Expert has an impressive and verifiable record of significant product, process and business improvements since 1980. These include: Time to market, new product development system improvement; Reengineering; Business unit performance and profitability ... See full profile

New Jersey (NJ), 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 Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). See full profile

Minnesota (MN), USA

Expert in Baby Diapers, Non-Woven, Absorbent Products, Films, Wipes, and Consumer Tissue & Towel
Has extensive experience in the development and evaluation of absorbent materials of all types for the management of all types of human exudates. This includes cellulose absorbent cores, superabsorbent materials, foams, fibers and non-woven absorbent ... See full profile

Pennsylvania (PA), USA

Expert in Hospital Tests and Kits, Clinical Chemistry, Coagulation, Serum Controls, Manufacturing Processes
Expert received his PhD in Biochemistry (Enzyme kinetics on NAD kinase in 1981), where he proposed a mechanism, Rapid Equilibrium Random with two dead end complexes for the enzyme, using enzyme inhibition studies. He was able to apply this ... See full profile

Washington (WA), 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 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 Device Strategy, Up-stream Marketing and Commercialization
Expert has over 30 years marketing experience in the healthcare industry. During his career he has launched over 20 products in the USA and internationally. Products launched include electronic medical equipment, durable medical equipment, medical plastic ... See full profile

Illinois (IL), USA

Expert in Drug and Vaccine Adverse Effects, Standard of Care, Hepatitis
Expert is board certified in internal medicine with a focus on biomedical clinical research. He received his PhD in immunology and medical genetics from the Department of Microbiology at UCLA in 1977. He also received his MD from UCLA in 1980 and ... See full profile

New Jersey (NJ), USA

Expert in EMC/EMI, RF/Microwave, Hardware, Firmware, Product Development
Expert has expertise in the design of biomedical imaging products, providing patient safety and comfort regarding ISO and FDA requirements. He is an Adjunct Professor teaching on biomedical instrumentation including cardiac, ultrasonic equipment, pressure ... See full profile

Arizona (AZ), 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 Quality Assurance, Regulatory Affairs, and New Product Development Consultant
Bs Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. See full profile

Illinois (IL), 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 Design & Development of Molecular IVD Assays, including Design Control, Risk Analysis, Submissions
Expert has 15 years' work experience in the development of nucleic acid -based in vitro diagnostic (IVD) devices. He has both theoretical knowledge and hands-on experience, spanning the entire IVD pathway, which includes biomarker discovery, ... See full profile

Washington (WA), 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 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, FDA 501K and PMAs
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 FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action in a ... See full profile

Michigan (MI), USA

Expert in Renewable Energy, Biofuels, Microelectronics, Semiconductor Packaging, Water Technologies, Agronomy
Expert has over 12 years of experience in Mergers & Acquisitions, representing both buyers and sellers. He has completed several deals and negotiated terms to maximize value. He has worked with clients to assimilate acquisitions regarding culture, economies ... See full profile

New York (NY), USA


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