Qualtech is pleased to invite you to our upcoming free webinar on Friday, April 17, 2026, focusing on how to effectively prepare and manage Technical Documentation under the EU Medical Device Regulation (EU MDR).
During this session, our European regulatory expert Dr. Arkan Zwick will share practical insights on developing robust and compliant technical documentation in accordance with the EU MDR requirements. The webinar will also include illustrative case studies covering both MDR and Annex XVI requirements, providing participants with practical examples of certification strategies. Additional focus is set on transitioning legacy devices to MDR compliance, and common pitfalls manufacturers encounter when working with Notified Bodies.
As the European Union remains one of the world's most important single markets for medical devices, this webinar will be highly valuable for all manufacturers currently active in, or planning to enter, the European market.
Key Discussion Topics
★ EU MDR Technical Documentation requirements
★ Case Study on dermal filler certification, covering both MDR and Annex XVI requirements
★ Practical insights on transitioning legacy products under the MDR
★ Do's and Don'ts when engaging with Notified Bodies
★ Regulatory Outlook for 2026
Webinar Information
▸ Date: Friday, April 17, 2026
▸ Time: 2.30 PM (GMT+8) | 8:30 AM (CEST)
▸ Speaker: Dr. Arkan Zwick, Regulatory Affairs Corporate Director at Croma-Pharma (Austria), with over 18 years of regulatory experience.
▸ Registration Link: https://forms.gle/dU37A5D7wr6hKZ1RA
Please note that this webinar is free of charge, but prior registration via the link above is required in order to receive the webinar access details. Furthermore, the registration form also allows participants to submit their questions related to the EU MDR before the event, so that they can be directly addressed by our expert during the live Q&A section of the webinar.
We look forward to welcoming you to this informative session and helping address the regulatory challenges you may currently face on your path toward EU MDR compliance. For any questions regarding the webinar or the registration process, please contact us at: globalra@qualtechs.com
