Notified Body designation and scope, the impact of Brexit and Competent Authority and Notified Body interpretation of the regulations. Make sure you are up to date!

MedTech Digital Week 2020 agenda revealed

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We're excited for the return of MedTech Digital Week. This year, the 3-day webinar series explores the latest updates on the EU MDR and IVDR. These free sessions will look at the recent MDR delay, requirements and implementation strategies, with practical advice from Competent Authority, Notified Body and industry representatives. It's free to join as many sessions as you like by clicking here.

To give you a flavour of what's in store, we've provided the full list of sessions on the agenda below.

Day 1 – Monday, 22 June

  • EU Medical Device Regulations, Notified Body Overview and Update from BSI with Jayanth Katta, Regulatory Lead, Medical Devices, BSI
  • Industry Feedback on the EU MDR Delay with Jeffrey Cyr, Senior Manager, Regulatory Affairs, Sirtex Medical, Inc
  • Unfolding MDR Through the Lens of a Remediation Partner with Vamsi Ravali, Regulatory Compliance Leader, Ajay Zinage, EU MDR Transition Leader & Monali Bhansali, PMS & CER Leader, Tata Elxsi

Day 2 – Tuesday, 23 June

  • Creating the Literature Review for a Comprehensive CER with Dr. Iveta Petrova, Product Lead, Elsevier B.V.
  • Enabling Remote Auditing with Technology: A Notified Body Perspective with Annemien Pullen, Director Strategy, Vault Medical Devices & Diagnostics, Veeva Systems, Andreas Purde, Unit Manager, Active Medical Devices, TÜV SÜD Product Service GmbH & Carl Ning, Sr. Director, Vault Quality Medical Device & Diagnostics, Veeva Systems
  • Path to Compliance: the EU MDR with Shokoufeh Khodabandeh, MDR Implementation Lead, Institut Straumann AG

Day 3 – Wednesday, 24 June

  • Competent Authority Viewpoint: Preparing for the IVDR with Steve Lee, Senior Regulatory Policy Advisory - IVDR, Medicines and Healthcare Products Regulatory Agency

Register for MedTech Digital Week

 

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