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We help you solve the puzzle

Regulatory Strategy

We think the best place to start is at the beginning. The Medavise team will help you determine the best regulatory pathway for your device and an action plan for obtaining market clearance.

510(k) | IDE/PMA | EU | ROW Submissions

Regulatory submissions can be complex at the best of times. Our team has the experience with FDA, EU Notified Bodies and Competent Authorities, and agencies in other countries such as Canada and Australia needed to expertly tackle your submission. And, we’re unique in our ability to help generate the content for your regulatory filing if needed:

  • Risk Assessment and other Design History File documentation
  • Manage pre-clinical verification and validation testing
  • Clinical investigations and Post-Market Clinical Follow-up (PMCF) studies


An Instructions For Use (IFU) is more than a regulatory formality, it includes the basis for your clinical performance claims which can direct the need for clinical evidence. Medavise can help tailor your IFU to fit your regulatory and clinical strategies.


– Clinical investigation
– Post-market surveillance
– User survey
– Clinical Evaluation Report (CER)


– Regulatory strategy
– Ongoing support
– Labeling
– 510(k), PMA, EU, ROW submissions

Quality & Engineering

– eQMS
– Ongoing support
– Design History File (DHF)
– Internal & vendor system audits

technical services

– Biostatistics
– Literature review
– Manuscript preparation