Having an experienced regulatory partner is invaluable when seeking acceleration of medical device regulatory approval, market introduction and understanding of the latest global regulatory requirements. With our medical device consulting approach, you maintain project control while gaining the benefit of on-demand external support—whether the goal is to extend your in-house capabilities or obtain access to the specialized expertise you need.

NAMSA is the industry leader in driving successful regulatory submissions and outcomes through effective, daily interactions with major global regulatory authorities. In fact, many of our Associates have previously held positions within these organizations, providing you the benefit of a clear understanding and proactive approach in meeting international requirements.

If you’re ready to learn how NAMSA can help you fast-track the delivery of your novel technology, including compliance planning to the EU Medical Device Regulation (MDR), please fill out the following form.

Some of our regulatory support programs include:

  • Clinical Evaluation Reports (CERs), Early State, New Submission and Maintenance
  • Post-Market Clinical Follow-up
  • Regulatory Assessment & Global Regulatory Strategy
  • Pre-Market Submissions: 510(k), PMA, IDE, BLA, HDE
  • Instruction for use (IFU), User Guide/Labeling
  • Periodic Safety Update Reports (PSUR)
  • Advisory Panel Preparation & Support
  • Quality Management Systems Creations, Implementation, Auditing and Gap Assessment
  • Regulatory Body Inspections
  • Management of Warning Letters, Regulatory Actions and Product Recalls
  • Notified Body Selection
Be sure to access our complimentary EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) planning resources here.
+1 866.666.9455 (toll free)
+1 419.666.9455 (outside of USA)

NAMSA Helps you Take the Guesswork out of Regulatory Planning

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