ORC Expert Advisory Services ORC International

  home    |    find an expert    |    request an expert    |    join our network    |    about us     expert login  
Expert Consulting and Expert Witness Services
  
  search tips 
Share this page:  Send to LinkedIn Send to Facebook Tweet This Email Print




Related Expert Areas

  

in vitro diagnostics

  

medical diagnostics

 • 

in vitro diagnostics Food and Drug Administration code

 • 

In Vitro Diagnostics Directive 98/79/EC

 • 

United Kingdom medical device reimbursement

 • 

in vitro toxicology

 • 

European Union Authorized Representative

 • 

United Kingdom borderline substance

 • 

United Kingdom healthcare expense reimbursement

 • 

clinical diagnostics

 • 

neurodiagnostics

 • 

cardiovascular diagnostics

 • 

CE Marking

 • 

FDA limulus amebocyte lysate test regulation

 • 

immunodiagnostics

 • 

medical diagnostic imaging

 • 

blood assay diagnostic instrumentation

 • 

medical diagnostic test development

 • 

Food and Drug Administration new drug code

 • 

biomedical diagnostic instrumentation

 • 

Food and Drug Administration regulation

 

In Vitro Diagnostics Experts

The following experts are available as in vitro diagnostics consultants and in vitro diagnostics expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  In Vitro Diagnostics - Measurement of quantities of biological markers in samples derived from the human body for the for the diagnosis and monitoring of diseases.

Synonyms:  IVD

Experts Only

Join our distinguished experts for in vitro diagnostics jobs, projects and consulting opportunities.


1 to 25
(of 52)
In Vitro Diagnostics Experts
Request Free
Expert Quote

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 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 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 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. See full profile

Texas (TX), USA

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 In Vitro Diagnostics, HPV, Women's Health
Expert was an HPV market manager at Digene where she oversaw the marketing of HPV to clinical laboratories. In that capacity, she trained and converted clinical laboratories and gynecologists to run/request for the HPV test in addition to pap. See full profile

District of Columbia (DC), USA

Expert in In Vitro Diagnostics Industry Including Clinical Laboratory, Immunohematology & Donor Screening
Expert's 40+ year career has spanned a variety of business disciplines and functions including information management, supply chain management, customer service, new product development, sales, and new business start-up. He began his career at Eastman ... See full profile

Georgia (GA), 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 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

Netherlands

Expert in Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for Lyme ... See full profile

New Jersey (NJ), 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 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 Technology Coverage and Reimbursement, Clinical Trial Design, Protocol Development
For thirteen years, Expert was National Medical Director of Coverage and Reimbursement for Aetna and Health Net. In those roles he was responsible for developing Medical Policies stating the coverage and reimbursement decisions of the company ... See full profile

Connecticut (CT), 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 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 ... See full profile

California (CA), USA

Expert in Virology, Drug Discovery, Diagnostics, Bioterrorism, and Vaccines
Expert has spent over 20 years in the pharmaceutical and diagnostics industries. During that time he has been involved primarily in viral vaccine and antiviral drug discovery, although he has also run ... See full profile

Suffolk, United Kingdom

Expert in Pharmaceutical and Biomedical Business Development, Technology Evaluation and Licensing
Expert is the founder and principal of Expert's Firm a firm engaged in business development, technology licensing, and product development, serving the pharmaceutical, biotech and medical device industries. His qualifications include ... See full profile

New Jersey (NJ), USA

Expert in Strategy and Sales Analysis for In Vitro Diagnostics and Biopharmaceuticals
Expert has multiple experiences in evaluating and proposing strategy for brands or individual products. This list includes several existing diagnostic products where lifecycle planning needs require judicious selection of new and novel add-ons to an ... See full profile

New Jersey (NJ), USA

Expert in Toxicology, Environmental Health and Safety, OSHA Regulatory, Mold, Healthcare and Laboratory Safety
Expert's experience is very broad in the areas of chemicals effects on humans and environmental systems. He has performed academic research on the effects of hazardous chemicals on the lungs, as well as carcinogenic effects of chemicals and air ... See full profile

Massachusetts (MA), USA

Expert in Internal Medicine, Hospital Medicine, Utilization Review, CMS Compliance, Faculty, Telemedicine
Expert is board-certified in Internal Medicine by the American Board of Internal Medicine. He has been practicing as a hospitalist (inpatient internal medicine) since finishing his residency training in 2007. He has worked in major, tertiary-care, ... See full profile

Florida (FL), 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 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 ... See full profile

Florida (FL), 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

>> Next 25 Experts
 
 

Need the right expert in in vitro diagnostics?  We can help!

home       find an expert       request an expert       join our network       about us

Intota is now ORC Expert Advisory Services

FOLLOW ORC ON