Simplifying Global Compliance
Clarity on Clinical Investigations – Webinar Recording/Transcript
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Clarity on Clinical Investigations: What You Need to Know About EU-MDR and ISO/DIS 14155:2018
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 presentation 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.
Presentation Takeaways:
By attending this presention, 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
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.
- 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
Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Mr. O’Leary has more than 30 years’ experience in quality, operations and program management in regulated industries including medical devices and clinical laboratories. He has a Masters Degree in Mathematics; is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.
