We're excited for the return ofMedTech 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 byclicking 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从BSI机智和更新h Jayanth Katta, Regulatory Lead, Medical Devices, BSI
- Industry Feedback on the EU MDR Delaywith Jeffrey Cyr, Senior Manager, Regulatory Affairs, Sirtex Medical, Inc
- Unfolding MDR Through the Lens of a Remediation Partnerwith 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 CERwith Dr. Iveta Petrova, Product Lead, Elsevier B.V.
- Enabling Remote Auditing with Technology: A Notified Body Perspectivewith 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 MDRwith Shokoufeh Khodabandeh, MDR Implementation Lead, Institut Straumann AG
Day 3 – Wednesday, 24 June
- Competent Authority Viewpoint: Preparing for the IVDRwith Steve Lee, Senior Regulatory Policy Advisory - IVDR, Medicines and Healthcare Products Regulatory Agency