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Expert in Quality Management Systems Medical Device ISO 13485 and 21 CFR Part 820
Implementing Quality Management Systems, Gap Analysis of Quality Management Systems, Quality Objectives, Organizational Consulting. Nonconformance/Complaint (backlog/recall) projects. MDR (MedWatch forms FDA), CAPA's, Certificate to Foreign Governments ... See full profile

California (CA), USA

Expert in Veterinary Epidemiology, Salmonella, Diarrheal Disease, Antimicrobial Resistance
Expert is a veterinarian with expertise in food animal production, Salmonella, E. coli, antimicrobial resistance, epidemiology and public health. She has experience in large animal practice, veterinary animal and public health legislation, public health ... See full profile

Vlaams Brabant, Belgium

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 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 Pulmonary and Critical Care Clinical Medicine
Expert is a busy clinical pulmonary physician who treats many patients with pulmonary diseases. He has been board certified by the American Board of Internal Medicine in Pulmonary Diseases for nearly 20 years. He reads pulmonary function tests ... See full profile

Indiana (IN), 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 Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination ... 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 Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. See full profile

Arizona (AZ), USA

Expert in Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as ... See full profile

Arizona (AZ), USA

Expert in Silicone Medical Devices and Implants, Product Development, Failure Analysis, etc.
Expert has both conducted and supervised studies of adhesion between various materials for approximately 28 years. These studies have included failure analysis and testing. They have mostly involved silicone elastomer adhering to itself, to ... See full profile

Michigan (MI), USA


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