Find an Expert

Expert ID: 734985 California, USA

Expert in Instrument Design and Development; Medical Devices, In-vitro Diagnostic Instruments; Clinical Laboratory Automation; Project Management; Planning, Scheduling, Budgeting. QSR and Design Control

Expert possesses a 30-plus-year track record managing medical device and in-vitro diagnostics development from concept to successful market introduction. A proven manager, he has accrued significant skills in leading diverse and multi-organizational teams in the successful development of leading edge,…

Expert ID: 729566 Illinois, 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…

Expert ID: 729362 Massachusetts, USA

Expert in Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology

ExpertSiek 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 QSR including Design History,…

Expert ID: 728004 United Kingdom

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 disciplines of research, development,…

Expert ID: 726880 Texas, USA

Expert in Allergy Immunology and Clinical Lab Immunology

Expert has a varied professional life. He has a busy private practice focused on hypersensitivity and immune disorders and asthma. He has unusual experience and recognition in dealing with food allergy of all types, including peanut anaphylaxis. The practice is…

Expert ID: 725075 Minnesota, 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). These products are generating over $100 million dollars in…

Expert ID: 725066 Florida, USA

Expert in Drug & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness

Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…

Expert ID: 724218 California, USA

Expert in Medical Device Software, Medical Device Software Engineering, FDA Compliance, FDA 501K and PMAs for Software

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. His responsibilities have covered the gamut…

Expert ID: 723840 California, USA

Expert in Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals

Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…

Expert ID: 728850 Washington, 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, preclinical & clinical assay validation,…

Dev Tool:

Request: experts/in-vitro-diagnostics-food-and-drug-administration-code
Matched Rewrite Rule: ^experts\/([^\/]*)\/?([^\/]*)\/?
Matched Rewrite Query: pagename=experts&searchKeyword=in-vitro-diagnostics-food-and-drug-administration-code&searchDiscipline=
Loaded Template: page-experts.php