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

 • 

medical device premarket approval

 • 

premarket approval assessment

 

'PMA' Experts


To improve your results, click a Related Expert Area on the left.

Experts Only

Join our distinguished experts for PMA jobs, projects and consulting opportunities.


1 to 25
(of 25)
PMA Experts
Request Free
Expert Quote

Expert in Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA ... See full profile

Minnesota (MN), USA

Expert in Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems ... See full profile

California (CA), USA

Expert in Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields ... See full profile

Massachusetts (MA), USA

Expert in Accident Reconstruction, Biomechanical, Mechanical, and Neuroelectrical Medical Device Engineering.
Expert understands brain, spinal and orthopedic biomechanics and has analyzed hundreds of cases to determine the causation of injuries sustained by drivers, workers and citizens. He has performed biomechanical research using cadaveric models to ... See full profile

Texas (TX), USA

Expert in FDA Regulatory Affairs, Compliance and Submissions
Expert is a former FDA reviewer with two decades of industry consulting experience in the following areas: GCP/TMF auditing, SOP writing, regulatory affairs, clinical development, submission preparation for drugs and devices, SAS programming, Part 11 ... See full profile

Maryland (MD), USA

Expert in Equipment Design and Manufacturing Processes: Automated Machine, ATEX-CENELEC & ISO Compliance, etc.
Expert managed and created the design and build of multiple machines and units used for paper converting, printing, plastics manufacture, packaging, food processing, aircraft components, vision inspection and material handling. See full profile

Florida (FL), USA

Expert in FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and ... See full profile

California (CA), 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 Product Approval and GMP Compliance to Medical Device Regulations
As compliance officer with the CDRH's Office of Compliance, expert was responsible for evaluating results of foreign and domestic inspections conducted by the agency based on current Good Manufacturing Practice Regulations. His experience with the FDA has ... See full profile

Virginia (VA), 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 Medical Devices
Expert is a medical device consultant and executive with more than 20 years experience in the medical device industry. His expertise spans all aspects of medical device commercialization, from medical device product development to medical device ... See full profile

California (CA), USA

Expert in Drug and Vaccine Adverse Effects, Standard of Care, Hepatitis
Expert is board certified in internal medicine with a focus on biomedical clinical research. He received his PhD in immunology and medical genetics from the Department of Microbiology at UCLA in 1977. He also received his MD from UCLA in 1980 and ... See full profile

New Jersey (NJ), USA

Expert in Medical Device Design and Manufacturing, Measurement Systems, Embedded Systems, etc.
Expert has extensive experience with biomedical imaging and medical diagnostic imaging as listed below: Cell Counting Used segmentation, clustering and classification techniques to count cells in fluorescent and scatter images. See full profile

California (CA), USA

Expert in Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due ... See full profile

Virginia (VA), USA

Expert in Process Automation, including: Control, Computer Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for ... See full profile

Indiana (IN), USA

Expert in Industrial and Aerospace Mechanism Design and Development
Tim Expert has twenty three years of aerospace new product design and development experience. Eighteen years of this experience was focused on designing, leading and directing new mechanism development at Expert's Firm, the leading mechanism design ... See full profile

California (CA), USA

Expert in Rebates, Rewards, Gift Cards, Consumer Protection, Promotion Deployment
Having managed 50,000 B-to-C and B-to-B marketing initiatives in virtually every imaginable sector, Expert has gleaned more information about how programs are deployed, received and interpreted than any resource in the country. See full profile

Minnesota (MN), USA

Expert in Metabolomics, Mass Spectrometry and Plant Pathology
Expert has developed expertise in metabolic reprogramming during susceptible and resistant interactions of Magnaporthe grisea with host plants, Brachypodium distachyon and rice as well as abiotic stress resistance in plants such as drought or cold ... See full profile

United Kingdom

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 Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition of ... See full profile

New Jersey (NJ), USA

Expert in Inkjet Printing Technology, Markets and Applications, Contract Manufacturing in China, etc.
He began development of a program in DuPont Imaging Systems to determine how DuPont would participate in digital printing technology as it grew to displace silver halide beginning in 1987. As a result of this effort he initiated and lead in the developed ... 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

Expert in Molecular Oncology, Cervical Cancer, Breast Cancer, Immunohistochemistry, Diagnostics, and Pathology
Expert trained as a classical molecular biologist using viral model systems to examine regulation of gene expression and DNA replication in bacterial and animal viruses. His post-doctoral work focused upon regulation and malignant transformation caused by ... See full profile

Illinois (IL), 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 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

 
 

Need the right expert in PMA?  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