FDA Provides Medical Device Curriculum

The Food and Drug Administration has an excellent resource for entrepreneurs to learn about design, testing, clinical evaluations and more for medical device development via Case Studies provided at:

http://www.fda.gov/Training/NationalMedicalDeviceCurriculum/ucm404245.htm

These medical device Case Studies cover such subjects as:

• ISO 14971
• Safety
• Risk
• Harm
• Hazard
• Hazardous Situations
• Cost of Federal Regulations, Title 21, Parts Covered: 21 CFR Part 807 Establishment, Registration, and Device Listing for Manufacturers and Initial Importers of Devices; 21 CFR Part 820 Quality Systems Regulation; and 21 CFR Part 860 Medical Device Classification Procedures.