FDA Regulatory Compliance and Submissions

XRTMED's deep expertise in FDA regulations and proven track record streamlines your product submissions. We'll manage the complexities, so you can focus on delivering innovative radiation therapy solutions to US patients.
  • Regulatory Strategy Development (510(k), PMA, De Novo, etc.)
  • Preparation and Compilation of Technical Documentation
  • FDA Communication and Representation
  • Post-Approval Compliance Support

Partner with us and set a course for success.

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