Countdown to IVDR Date of Application – Key Requirements and Challenges

Preparing for the In Vitro Diagnostic Device Regulation (EU) 2017/746 (IVDR) will require manufacturers to develop new practices, apply new concepts, and potentially develop entirely new procedures in order to comply with the new standards. This webinar walks you through key milestones as your company prepares for the IVDR date of application in May 2022, including:

  • Quality Management System standards to address IVDR Article 10
  • Outlining a gap analysis between IVD and IVDR requirements
  • Annex II requirements for your Technical Documentation
  • Revised agreements with your Economic Operators
  • Confirming your Notified Body will be designated to IVDR

ABOUT THE PRESENTER

Ken Pilgrim has over 20 years of industry experience at the Manager/Director level, overseeing corporate quality systems and providing input on business decisions and strategy, regulatory oversight, and risk management strategies for existing and new products.

This webinar was recorded on August 26, 2021.