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When you’re looking
out for the world,
we’re looking out for you.

Your Team of Med-Tech Experts


– 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

Even a genius needs a wingman®

Bringing new products to market is never easy. When it’s a medical device with the potential to affect lives, it’s even harder. At Medavise, we’ll help you navigate all necessary regulatory agencies while we keep raising the bar on quality control to get your product where it needs to be—in the hands of medical professionals seeking the best options to help their patients.

Our staff is committed to you
and will stand by your side.

1. Setup a meeting to find out the project details.

2. Put together a proposal (statement of work).

3. Get to work.

Give us a call today

Don’t leave without this!

Key Questions to Ask of a Potential Clinical Evaluation Report Partner

Don’t leave without this!

Top issues to look for in getting regulatory approval.