EU MDR Consulting
Fang Consulting demonstrates EU-MDR implementation expertise.
Fang Consulting team members are full-time employees and career professionals. We have the resources to provide a unique team built to meet YOUR needs. We can offer a single Consultant Strategist or a team managed by a Senior Consultant to work side-by-side with your client team to drive your projects. Fang’s deep collective expertise and experience in EU-MDR assures the development of an effective regulatory strategy.
Countdown to EU MDR
*EU MDR compliance requirements take effect on May 26, 2020.
- Device Classification Review
- Analyze product documentation current-state vs. future-state
Quality System Gap Assessment
Design Dossier & Tech File Gap Assessment
- Outline specific documentation changes between MDD and MDR for your products
Gap Assessment of Key Chemical / Material Restrictions (such as those found in REACH, RoHS, BPR & CLP)
- Reproductive Toxins
- Endocrine Disruptors
Gap Response Plan
Notified Body Submission / Response
Post-Market Surveillance Services
- Vigilance Reporting
- Trend Reporting
- EUDAMED Database Updates
Clinical Evaluation Reports
- MedDev 2.7.1 Rev. 4
- MDR Updating
- On-Site training and overview of EU MDR
- Customer/Class Specific Requirements
- Clinical Evidence Strategies
- Implementation Best Practices
Want to Learn More about EU MDR Consulting?
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Find out more about Fang Consulting and the Regulatory Affairs, Quality, and Fulfillment services we provide.