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premarket approval assessment


product-related assessment


medical device premarket approval


Pre-Investigational Device Exemption Submission


Pre-Investigational Device Exemption Process


Investigational Device Exemption


drug product approval


510(k) document


Food and Drug Administration




new drug application


medical device


Premarket Approval Assessment Experts

The following experts are available as premarket approval assessment consultants and premarket approval assessment expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Premarket Approval Assessment - A product-related assessment process usually involving a drug or medical device, in which its safety and effectiveness is evaluated before it can be placed on the market for sale.

Synonyms:  PMA, pre-market approval

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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 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 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 has been ... See full profile

Massachusetts (MA), 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

Delaware (DE), 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 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 Expert Witness Services, Product Development, product Design, Project Management
Expert has been directly involved in the development of medical devices and their manufacturing processes for nearly forty years. These included ten years of responsible positions in industry, as well 30 years as the president of ... See full profile

Washington (WA), USA

Expert in General Management; Finance, Accounting, Sales, Marketing, IT, Manufacturing, Strategic Planning
Expert has extensive hands on experience in all aspects of accounting. He has established activity based cost systems and selected and implemented various accounting software applications, such as Peachtree and Oracle ERP. See full profile

Wyoming (WY), USA

Expert in Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in ... See full profile

Pennsylvania (PA), USA

Expert in Automated Chemical Sensors
Laboratory computerized analytical instrumentation design; chemical autoanalysis. Expert has spent much of his career developing systems or subsystems for devices accomplishing automated chemical analysis. He has experience in all ... See full profile

Massachusetts (MA), USA


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