RAPS Regulatory Convergence


This annual event hosts the global regulatory community and brings together the profession’s best and brightest to learn, grow, lead and share.

Don’t miss LRQA’s presentation:
A Notified Body’s Perspective – Managing the Impacts of EU IVDR and MDR - Tuesday, September 12 2017 at 2:45pm – 3:30pm

Find out what the IVDR & MDR Regulations mean to your organization - LRQA presents the top frequently asked questions.

With the publication of the new IVDR and MDR regulations, regulatory affairs professionals and device manufacturers are seeking clarification on how to implement the new requirements within their organizations. These new regulations tighten and strengthen the approval system and introduce several key changes that manufacturers will need to implement, including:

  • Scope of regulated medical devices and IVDs
  • Identification and traceability
  • Pre-market scrutiny procedure
  • Classification and conformity assessment requirements

Join this session and find out answers to the industry’s frequently asked questions for a better understanding of the key changes, impacts, transition phase and steps to be taken. 

Speaker:  Nick Baker, Medical Devices Technical Manager (IVDR) – LRQA
Nick Baker - LRQA