Regulatory guidance is a critical component of a successful product development program.
At MSC, we understand how to navigate the international regulatory landscape to expedite product approvals. MSC offers a variety of operational and strategic consulting services to facilitate interactions with regulatory agencies and IRBs/ethics committees.
Regulatory Affairs services include:
- Clinical development planning
- Pre investigational device exemption (Pre-IDE)
- Investigational device exemption (IDE)
- Pre-market notification (510k)
- Pre-market approval application (PMA)
- Humanitarian device (HUD)
- Humanitarian device exemption (HDE)
- Clinical Evaluation Reports (CER)
- Summary of Safety & Effectiveness Data (SSED)
- Clinical study reports
- Reimbursement strategies
- Agency audit support and warning letter resolution
- SOP development