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In Vitro Diagnostics Directive 98/79/EC


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'EC' Experts

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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 Food Processing, Food Safety, Food Hygiene, Food Business Advice
Excellent knowledge of EC food safety policy and regulatory framework; Outstanding experience in developing, planning and implementing of food safety programmes (EC Countries, EC Candidate Countries, potential EC Candidate Countries, CIS-Countries, ... 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

Expert in EU Environmental Policy and Law: Environmental Impact Assessment; Water and Waste Management
Expert has achieved skills in providing enterprises with decisional support to manage waste concerns and to integrate them into operational activities. His claim is to follow up the European waste policy and to point out the potential needs for ... See full profile


Expert in Avocado Fruit Production, Orchard Management and Botany, Nursery Management and Clonal Propagation Procedures
Expert experience in horticulture research includes 10 years of research on avocado (Persea americana) including rootstock selection and evaluation, pruning techniques, post harvest fruit evaluation, and simulated shipping. He serves as Commercial ... See full profile

Queensland, Australia

Expert in Water Pollution, Toxic Chemicals, Pesticides
Expert's specialty is in the analytical chemistry of natural and anthropogenic compounds. She has used modern chromatography and spectroscopy instrumentation for analysis of organic and inorganic compounds in air, water and soil. See full profile

Texas (TX), USA

Expert in Engineering and Safety Standards
Expert has expertise in standards. He devotes approximately 75% of his time to working with international (ISO and IEC) and European (CEN and CENELEC) standards with a primary emphasis on safety aspects related to machinery as ... See full profile

Wisconsin (WI), USA

Expert in Human Rights of Persons in Custody; Criminal Investigation; Law Enforcement Services
Expert has over ten years of international work experience in the area of police investigation, law enforcement, police and prison reform issues as well as in project management. She is a criminal justice lawyer and was a police inspector who ... See full profile

Bosnia & Herzogovina

Expert in Systems Management, Databases, Linux, Biodiversity informatics, Ecological Niche/Envelope Models
Started his career as research assistant (marine ecologist, analyst) at the Fishery Research Lab and Marine Research Centre in his native town (Klaipeda, Lithuania) by observing patterns of benthic and fish communities of the Baltic Sea and Curonian ... See full profile

United Kingdom

Expert in Environmental Analysis and Forensic Ecology
Environmental forensics The field of environmental forensics is an emerging discipline, and covers a wide range of environmental sciences. Expert specialises in forensic ecology - the examination of environmental accidents, especially (but not ... See full profile

Cumbria, United Kingdom

Expert in Environment, Sustainable Development, Climate Change, Resilience, Vulnerability
Hse, ems, iso 14001, qa, iso 28000, auditing, compliance, due diligence, fatal flaws analysis, accreditation. Facility experience: ports and harbours, offshore and onshore oil and gas installations and support services & facilities, rail infrastructure, ... See full profile

Wiltshire, United Kingdom

Expert in Tea Cultivation, Processing and Marketing; Organic Tea, Organic Certification & Third Party Auditing
Expert took over charge of Tea Board of India's Darjeeling Tea Research and Development Centre in 1988 as Director. He spent 18 years with the Tea Board of India and provided professional support to the stakeholders, government departments, scientists ... See full profile


Expert in Problem Solving, Project Management & Rescuing, Automation, Security & Safety, SWE, RTD, QA
Achieved his MSc in Electronic Engineering (Politecnico di Milano) plus additional qualifications in ICT System Management (SDA-Bocconi) and Software Engineering (IBM-IFDA) and many others. Due to personal reasson he started his working experience very ... See full profile

Berkshire, United Kingdom

Expert in Microfinance, Microenterprise, Livelihoods, Value Chain, PSD,Economic & Financial Analysis, PME, ROM
* “Shrimp and Fish Culture Development Project” The project aimed at livelihood support to people below poverty line and, was developed and implemented through public-private partnership. As a management consultant, worked out economics of the project ... See full profile

Orissa, India

Expert in Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and ... See full profile

California (CA), USA

Expert in Tunnel Ventilation, Tunnel Safety, Smoke Control and Building Aerodynamics
Profound expertise in aerodynamics and smoke management in tunnels. Application of the following guidelines and standards: RABT (Germany), ASTRA (Switzerland), RVS (Austria), EU 2004/54/EC (EU), PIARC (worldwide). Support of FAT, SAT and fire tests. See full profile


Expert in Medicine and Biotech Materials, Polymers, Nanoparticles, Peptide and Protein Chemistry
Expert has a MSc in chemical engineering and a PhD in pure and applied biochemistry. Her PhD thesis was on enzyme technology (enzymatic synthesis) and molecular imprinting (preparation of chiral liquid chromatography stationary phases). See full profile


Expert in Agriculture, Food Product Labeling, Regulation and Standardisation
Professional experience: 1999-2003 Czech agriculture and food inspection - Chief of control department Check in the field, creation plans for control, education of inspectors for check of fresh fruit and vegetables and dry fruits 2003 – 2008 Czech ... See full profile

Czech Republic

Expert in Refractive Eye Surgery, Including LASIK, PRK, Phakic IOLs, Intacs, LASEK, epi-LASIK
Expert is a board certified ophthalmologist, whose practice has been limited to refractive surgery since 1993. He has performed over 40,000 refractive surgical procedures, including over 6,000 radial keratotomy (RK) surgeries, 10,000 photorefractive ... See full profile

California (CA), USA

Expert in Arthritis and Collagen Research
Expert has expertise in and has established many animal models of disease at multiple institutions. These include models of human rheumatoid arthritis (RA) such as collagen-induced and adjuvant-induced arthritis in rodents. See full profile

Washington (WA), USA

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