Top

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.

Impact Assessment

  • 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

Mock Audit

Gap Assessment of Key Chemical / Material Restrictions (such as those found in REACH, RoHS, BPR & CLP)

  • Carcinogens
  • Mutagens
  • 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

Training

  • On-Site training and overview of EU MDR
  • Requirements
  • Timelines
  • Customer/Class Specific Requirements
  • Clinical Evidence Strategies
  • Implementation Best Practices

Want to Learn More about EU MDR Consulting?

Please fill out the form below and one of Fang Consulting’s Consultants/Strategists will followup with you.


Find out more about Fang Consulting and the Regulatory Affairs, Quality, and Fulfillment services we provide.