If you have any questions or would like to speak with a Business Improvement Services representative regarding our Services or Training please e-mail us at info@businessimprovementservices.com or call us at 440-725-1022
Center for Devices and Radiological Health / CDRH
Document Name
Medical Device Quality Systems Manual
Resources
Overview of Regulations
Workshops
Guidance Documents
CDRH Databases
Code of Federal Regulations
International Information
Consumer Information
CDRH Learn
Premarket Information
Is Your Product Regulated?
Classify Your Device
How to Market Your Device
510(k)/GMP Exemption
Device Labeling
Premarket Submissions
Premarket Notification 510k
Investigational Device Exemption(IDE) for Clinical Studies
Premarket Approval (PMA)
Humanitarian Device Exemption (HDE)
Postmarket Information
Establishment Registration
Device Listing
Quality Systems for Manufacturing
Medical Device Reporting for Adverse Events
Recalls/ Corrections and Removals
Importing Devices
Exporting Devices
Medical Device Tracking
Postmarket Surveillance Studies
