May 15, 2019

EU MDR Consulting

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.

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 Consultant/Strategist will followup with you.

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