– Clinical investigation
– Post-market surveillance
– User survey
– Clinical Evaluation Report (CER)
– Regulatory strategy
– Ongoing support
– Labeling
– 510(k), PMA, EU, ROW submissions
– eQMS
– Ongoing support
– Design History File (DHF)
– Internal & vendor system audits
– Biostatistics
– Literature review
– Manuscript preparation
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.
1. Setup a meeting to find out the project details.
2. Put together a proposal (statement of work).
3. Get to work.
Don’t leave without this!
Don’t leave without this!