It is a complex process to create an actionable roadmap to IVDR compliance. We help you determine whether your products fall under the scope of 'in-vitro diagnostics' according to IVDR 2017/746/EU. We also help with Medical Writing: Performance Evaluation Plan, Performance Evaluation Report, Clinical Performance Report as well as Post-Market Performance Follow-Up Plan (PMPF).

Further information regarding services, expertise and how our experience can support your business; please contact us at +4526709648, Email: info@slet-dette.toxregulatoryaffairs.com

IVD Regulation in U.S.
We offer the following regulatory strategy and submission services:

Clinical Study design on Emergency Use Authorization (EUA) devices

  • Clinical Study design on Emergency Use Authorization (EUA) devices
  • Submission of EUA device Application
  • 510(k)submission
  • Biologics License Application (BLA)
  • Breakthrough Device Program Submission
  • Premarket Approval (PMA) Submission
  • De novo Submission

Further information regarding services, expertise and how our experience can support your business; please contact us at +4526709648, Email: info@slet-dette.toxregulatoryaffairs.com