Biomedical Engineering Research: Industry & Product Research
Intro
Medical device research is an area that can be important to biomedical engineers. Below find some resources for researching medical device regulations in the United States, as well as resources for market and industry research. If you have questions, please contact the Engineering Librarian.
FDA Medical Device Regulations & Resources
- Center for Devices and Radiological Health (CDRH)
Branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. - Device Advice: Comprehensive Regulatory Assistance Device Advice, is the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) web page for comprehensive regulatory information, explains the many aspects of medical device laws, regulations, guidances, and policies.
- Device Labeling
- Product Classification for Medical Devices
FDA database that lists all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. - FDA Medical Device Databases
- How to Study and Market Your Device Explains the steps one must take prior to marketing a medical device in the United States.
- Quality System Regulation (QS) / Good Manufacturing Practices (GMP) Includes requirements related to designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.
Business Information / Marketing Reports / Directories
- Gale Business: Insights This link opens in a new windowDetailed company and industry reports, profiles, and news.More InfoFull-Text UB ONLY
- Business Source Complete This link opens in a new windowBusiness-related research and information. More InfoPartial Full-Text UB ONLY
Product Information / Suppliers
- QMed
Directory of suppliers to the medical device industry.