Europe’s new Medical Devices Regulation 2017/745 (MDR) is finally here and takes effect in May 2020. If you need help with MDR transition strategy, gap assessments, or simply getting up to speed quickly on the MDR requirements, check out our MDR Training and MDR Consulting options.
Meditrial has assisted multiple medical device companies with QA/RA compliance. We can provide you tools and suggestions to successfully enter the age of the MDR.
Meditrial’s expert consultants can identify the best transition strategy for your company based on your product range, certification cycle, markets you serve, and your Notified Body.
Meditrial can help you from start to finish
- CE Marking technical file or design dossier
- Current device class and product families
- Risk management file review
- Clinical evaluation report(s)
- Post-market surveillance (process, plan, effectiveness, PMCF, and results)
- Economic operators agreements review, including your European authorized representative (EC REP) agreement
- Supply and distribution chain management procedures
- Relations with your current notified body
- Product life cycle plan