Dunes Medical Writing is the expert guide for your journey through EU MDR clinical evaluation. Our experts have walked the path and can help you through the unknown to reach your goal efficiently.
EU MDR
Clinical Evaluation
Our expert consultants have worked for top medical device companies in various specialties leading MDR transition projects for all classes. We have seen the audit results and learned potential pitfalls that can lead to non-compliance.
Customized Service to Fit Your Needs
We can customize our services to fit your needs. Are you struggling with certain aspects of clinical evaluation that need extra help?
- CEP: Literature review strategies, preliminary searches, equivalence, route of conformity, expected performance rates
- CER: Literature screening and appraisal, data analysis and summary, statistical analysis
- PMCF plans/reports and SSCPs
- MDR readiness assessment
- Template review & development
Pick Our Brain!!
We have compiled and distilled our experience with EU MDR clinical evaluation in our knowledge center where you can find potential deficiency responses from NB reviewers and common pitfalls of MDR transition. You can also leave a question and we will provide an answer!
Small Project? No Problem!
We pride in providing service to all sizes of companies and budget. We will provide straightforward pricing at the beginning of the discussion to gauge feasibility. You can customize our service down to different elements of clinical evaluation to manage your budget. You will not be surprised with huge invoices due to unpredictable billing schemes.