EU MDR Consulting
The transition period for the new EU Medical Device Regulation (MDR) is quickly approaching, is your company in compliance?
On May 26, 2021, the new EU MDR changes will become mandatory and all requirements enforced. Fang Consulting can make sure you are fully equipped and in compliance with the new EU MDR regulations.
The Fang Consulting team are experts on how the new EU MDR regulations will change current medical device processes and requirements. From structuring a clear timeline to conducting a strategic gap analysis to providing EU MDR training for continuous progress, we ensure your implementation process will meet the deadline with the specialties necessary to accurately advise the transition.
Our staff provides EU MDR guidance at each step of the way so your company transitions efficiently and successfully.
Our EU MDR Services
Impact Assessment
- Medical device classification review
- Analyze product documentation current-state vs future-state
Design Dossier & Tech File Gap Assessment
- Outline specific documentation changes between EU MDD and EU MDR regulations for your products
Gap Assessment of Key Chemical/Material Restrictions (Such as those found in REACH, RoHS, BPR, & CLP)
- Carcinogens
- Mutagens
- Reproductive Toxins
- Endocrine Disruptors
Quality System Gap Assessment
Mock EU MDR Audit
Gap Response Plan
Notified Body Submission/Response
Post-Market Surveillance of Medical Devices
- Vigilance reporting
- Trend reporting
- EUDAMED database updates
Clinical Evaluation Reports (CER)
- MedDev 2.7.1 Rev. 4
- MDR Updating
Training
- On-site EU MDR training and overview
- Requirements
- Timelines
- Customer/class-specific requirements
- Clinical evidence strategies
- Implementation of best practice