EXPERTS IN MEDICAL DEVICES, IVDs,
COMBINATION PRODUCTS, AND BIOLOGICSThe Regulatory & Clinical Research Institute, Inc. (RCRI) knows medical devices, IVDs, combination products, and the biologics. Our growing staff of highly qualified professionals will provide you with the exact services needed to achieve the best results in this dynamic marketplace. Wide-ranging Medical Expertise
RCRI’s work has involved many medical specialties including: - Anesthesiology
- Biologicals
- Cardiology
- Dental
- Gastroenterology
- Infection control
- In-vitro diagnostics
- Microbiology
- Neurology
- OB/GYN
- Ophthalmology
- Orthopedics
- Plastic Surgery
- Radiology
- Respiratory
- Spinal
- Urology
- Wound healing
Expanding Networks Through Leadership
RCRI professionals are well networked with experts and key opinion leaders in clinical practice and at regulatory agencies. RCRI professionals participate actively in organizational activities involving government, academia, and industry and hold significant leadership positions including: - Technical Advisor to the FDA on pharmaceutical technology and medical device manufacturing
- ASTM consensus standards author
- Co-editor and chief, RAPS book, US Fundamentals of Regulatory Affairs
- Statistician Data Safety Monitoring Boards
- Statistician Pivotal Study Steering Committee
- Co-chair of the Medical Alley Regulatory Affairs and Clinical Affairs special interest groups
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