The world of clinical investigations is changing rapidly, with the EU-MDR’s new and more complex system and the forthcoming ISO/DIS 14155:2018 updates.
This webinar will provide insight into the EU-MDR’s extensive requirements for documenting, conducting and reporting clinical investigations, including which devices are exempt. Manufacturers of non-exempt devices must set up a clinical investigation system using both EU-MDR and ISO/DIS 14155:2018. The interplay between the two is explained through an exploration of Annex ZC.
Why not let noted expert, Dan O’Leary, explain these requirements and concepts in his comprehensive, easy-to-understand approach? Mr. O’Leary, President of Ombu Enterprises, LLC, will provide valuable insight into the EU-MDR’s extensive requirements for documenting, conducting and reporting clinical investigations, including which devices are exempt.
By attending this webinar, you’ll:
- Understand the role of clinical investigation in the EU-MDR
- Learn which device types require clinical investigations
- Learn the exemptions and determine whether one applies to your device
- Understand the system for clinical investigation
- Learn how to integrate the EU-MDR and ISO/DIS 14155:2018
- Understand the role of the Notified Body and Competent Authority
- Learn the ins and outs of putting a CE Mark on a device
Bonus! Attendees will get an EU-MDR checklist for clinical investigation.
Make sure you fully understand the EU-MDR’s and ISO/DIS 14155:2018’s clinical investigation requirements — how they work together and how to make them work for you. Join us by registering today.
Who Will Benefit
- Design Engineering Managers
- Design Project Leaders
- Quality Managers
- Regulatory Managers
- Regulatory Specialists
- Risk Managers
- Clinical Affairs Managers
- Clinical Affairs Specialists
- Purchasing Agents
- Supplier Quality Engineers