ISO 5840 Virtual Training for EU Notified Bodies and Legislators with Ajit Yoganathan, Ulrich Steinseifer, Changfu Wu, Jeffrey Borer, Stephen Hilbert, Dario Pirovano and Bassil Akra
(To calculate the correct time zone, please feel free to use the button “Time zone converter” and use Berlin as a reference European Time)
The ISO 5840 standard has been recently revised to address the new knowledge and techniques in heart valve substitute technology. It is applicable to newly developed and modified heart valve substitutes intended for implantation, including respective accessory devices, with emphasis on providing specific guidance for in vitro testing, preclinical in vivo and clinical evaluations, reporting of all in vitro, preclinical in vivo, and clinical evaluations, as well as labelling and packaging of the device to be implanted. The standard consists of three parts, whereby ISO 5840-1 provides general requirements, i.e., for all types of heart valves, ISO 5840-2 provides specific requirements for surgical heart valve substitutes and ISO 5840-3 for transcatheter heart valve substitutes.
With this virtual event, a group of key subject matter experts will provide an opportunity for the EU Stakeholders such as Notified Bodies, Competent Authorities, EU Commission Members, and other regulators to understand the reason for the changes implemented in this standard series and their correct application when showing compliance to EU Legislations. Medical device experts will also have the ability to attend and raise their questions to key experts in this field enabling them to apply the standard in a harmonized and compliant way.
- Opening remarks
- Introduction and background details on the revision of the ISO 5840
- What is new with the new standard series?
- In Vitro Testing Requirements
- Pre-clinical Requirements
- Clinical and Post-Market Requirements
- Clinical Requirements with the Medical Device Regulation: News and Challenges
- Panel Discussion – Ajit Yoganathan, Ulrich Steinseifer, Changfu Wu, Jeffrey Borer, Stephen Hilbert, Dario Pirovano and Bassil Akra
- Closing Remarks
- Start 04:00 PM – End 07:00 PM. Attendees are recommended to login 15 min in advance.
In order to keep the training interactive, the exact content schedule cannot be provided.
Certification:Personal Certificate will be provided in PDF
Presentation:Presentation will be provided in PDF