Medical Device Regulations in Europe
Fang Consulting proves EU-MDR consulting and implementation expertise
Source the team that best fits your needs to take you into EU MDR compliance through Fang Consulting's EU MDR consulting services. We can offer a single Consultant / Strategist, or a team managed by a Sr. Consultant that can work side-by-side with your existing team to move your project along. Our team's knowledge of the European Medical Device Regulation (EU-MDR) ensures that we can train and support you with an efficient and 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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