REGULATORY


Developing the right regulatory approach is equally as important as developing a quality product. We have extensive experience navigating the regulatory landscape and a proven track record of successful executions.

In collaboration with our innovators, our group will create and compile the technology’s Design History File as we prepare for FDA submission or registration. Leverage our product experience to conduct and coordinate all of your Verification and Validation activities.

  • Regulatory Strategy
  • Execution on Regulatory Plan
  • Class I, II, and III Devices
  • 510(k) Generation, Review, and Submissions
  • De Novo Submissions
  • Product/Packaging Validation
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