Our medical device consultants help you avoid regulatory setbacks
- FDA, EU, and Health Canada regulatory management
- Quality management – GMP and QMS auditing (ISO 13485, FDA Part 820, MDSAP)
- Risk management
- 510(k) submissions – medical devices and in vitro diagnostics
- PMA assistance
- FDA warning letter and Form 483 remediation activities
- Combination device assistance
- CE Marking assistance
Medical Device Regulatory Consulting
Helping our clients meet medical device regulatory compliance standards at every stage of development.