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In Vitro Diagnostics Directive 98/79/EC


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in vitro diagnostics


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Experts in In Vitro Diagnostics Directive 98/79/EC

The following experts are available as In Vitro Diagnostics Directive 98/79/EC consultants and In Vitro Diagnostics Directive 98/79/EC expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  In Vitro Diagnostics Directive 98/79/EC - The CE marking of in vitro diagnostics (IVDs) in accordance with the EU In Vitro Diagnostics Directive.

Synonyms:  IVD Directive 98/79/EC

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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 Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, ... See full profile

California (CA), USA

Expert in Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. See full profile


Expert in Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet ... See full profile

Massachusetts (MA), 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 Devices; Product Development, Manufacturing, Marketing, Business practices, IP
Expert has been the CEO or chairman of 7 medical device companies in 4 countries - 4 public, 3 private, and has been a member of the Board of Directors of 8 companies. He is an expert in all areas of general and specific management of a medical device ... See full profile

Minnesota (MN), USA

Expert in Medical Devices and Biopharmaceuticals Design, Development, Manufacturing, and Business Development
He has a broad scientific and managerial experience of the healthcare industry, both public and private sectors, and both products and services . His experience encompasses the medical device, biopharmaceutical and health services sectors and the ... See full profile

Scotland, United Kingdom


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