FDA
FDA www.fda.gov
Medical Devices http://www.fda.gov/MedicalDevices/default.htm
CFR - Code of Federal Regulations Title 21
Quality System (QS) Regulation / Medical Device Good Manufacturing Practices
Medical Device Quality System Manual - A Small Entity Compliance Guide
- Supercedes the Medical Devices Good Manufacturing [GMP] Practices Manual
FDA Inspection Guides http://www.fda.gov/ICECI/Inspections/InspectionGuides/default.htm
- Quality Systems http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm
- Medical Device Manufacturers http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm
Forum on 21 CFR Part 11