Medical Device Academy, Inc. provides solution-based regulatory consulting and continuing education training services to medical device manufacturers, including:
1. Regulatory Submissions [e.g., 510(k), CE Marking and Canadian Medical Device Licensing]
2. Regulatory Compliance (e.g., mock-FDA inspections, ISO 13485 certification and CAPA)
3. Continuing Education Training--web-based, public and private in-house training courses
Clients that have urgent needs where time to market is critical, turn to us. Our passion is teaching medical device professionals how to prepare for future regulations and self-monitor compliance so that they can avoid compliance remediation.