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Medical Device Software Development & Regulatory.

We help Medtech companies create and clear Software as a Medical Device (SaMD). Additionally, we can develop your regulatory strategy, build your software (including AI/ML and cybersecurity), draft your design documents, and submit your FDA 510(k).

Our team of software engineers and regulatory consultants has been helping medical device companies get onto the market since 2012. We operate at the intersection of software engineering and regulatory guidance.

  • Undisclosed
  • Undisclosed
  • 10 - 49
  • Founded 2012


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