Regulatory Affairs

MEDIcept has proven experience helping clients successfully meet regulatory requirements. MEDIcept personnel have been part of and submitted over 100+ FDA 510k and PMAs. MEDIcept has extensive knowledge of FDA regulatory requirements for 510K, IDE, BLA, and PMA submissions and annual reports, as well as validation plans and procedural development.

We can help our clients though our relationships with the Agency and ISO notified bodies. MEDIcept consultants have provided a conduit to the FDA and other regulatory bodies to support our clients in clinical studies, submissions, and regulatory compliance issues. Our consultants have been on international boards of recommendation and working groups developing policy. We have first hand knowledge of the personnel regulating and ensuring compliance to these policies.

Regulatory Strategy
- Compliance audit assistance
- Submission strategy
- FDA required documentation
- Warning letter remediation
- Corrections & Removal Advice		 Regulatory Consulting
- Regulatory Submissions (PMA, 510K, BLA, IDE, CE)
- Mock FDA, Canada, and ISO Compliance Audits
- Label and Labeling Compliance Review
- US Agent for international companies

 

 

Capabilities

  1. Regulatory Affairs
  2. Quality Systems
  3. Patent Searches and
    Applications

– Paul Fenton,
Founder and CEO, Axya Medical, Inc.