July 17, 2018

Fang Consulting’s EU MDR services include:

  • 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
  • Gap Response Plan
  • Clinical Evaluation Reports
    • MedDev 2.7.1 Rev. 4
    • MDR Updating
  • Mock Audit
  • Notified Body Submission/Response
  • Post-Market Surveillance Services
    • Vigilance Reporting
    • Trend Reporting
    • EUDAMED Database Updates
  • Gap Assessment of Key Chemical/Material Restrictions (such as those found in REACH, RoHS, BPR & CLP)
    • Carcinogens
    • Mutagens
    • Reproductive Toxins
    • Endocrine Disruptors
  • Training
    • On-Site training and overview of EU MDR
      • Requirements
      • Timelines
      • Customer/Class Specific Requirements
      • Clinical Evidence Strategies
      • Implementation Best Practices

With Fang Consulting, you are able to source the team that best fits your needs to take you into EU MDR compliance.  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.