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Based on our extensive training experience in the FDA Medical Device space, we are available to assist clients with training opportunities as follows:
- 21 CFR 50 AND 56, 21 CFR 812, 21 CFR 820 Basic Requirements
- Domestic and International companies
- FDA Quality System Inspectional Technique (QSIT). Mock FDA Inspections of medical device companies
- FDA Inspectional readiness in all program areas (medical devices, principal investigators, sponsors, CROS)
- FDA-483, Inspectional Observations and Warning Letter Responses
- Internal auditor training to “inspect” like the FDA Investigators
- CAPA implementation including root cause analysis
- Design control development and implementation
- Assistance in the development of client specific training
