Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide, therefore you can count on us for in-depth and up-to-date insights which increase speed-to-market.
Our Medical Device Regulatory Affairs services include:
- New Product Approval Support
- Post Approval Support
- Other Regulatory Services
- U.S. Agent Services
- EU Medical Device Regulations (MDR)