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@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