Regulatory Compliance

  • Regulatory Pathways
  • 510k/IDE/HDE/PMA
  • Technical Files
  • FDA Registrations
  • Medical Device Validation
  • Canadian Licensing

Taking the WORK out of your paperwork!

OMEDtech can provide US agent services for companies based outside the US as required by FDA regulations.

We also provide medical device clinical study services including: Pre-submission (pre IDE) consulting and planning, small size clinical trial design, clinical study development, implementation of clinical trials, clinical study management and monitoring services.

Learn more

Give us a call at: +1 405 227 9060 or send us a friendly email.

Let’s Connect