Medical Device Trials in the EU: A Guide to the New EU-MDR and Revised ISO 14155
If your device requires clinical trials under EU-MDR, there’s a lot to learn.
The world of clinical trials is changing rapidly, with the EU-MDR’s new and more complex rules and the forthcoming ISO/DIS 14155:2018 updates. With all the requirements found in different places, you could spin your wheels searching through article after article, jumping to annexes and back to more articles.
The Medical Device Trials in the EU: A Guide to the New EU-MDR and Revised ISO 14155 management report explain these requirements and concepts in a comprehensive, easy-to-understand approach:
- Understand the role of clinical trials in the EU-MDR
- Learn which device types require clinical trials
- Determine whether an exemption applies to your device
- Learn how to integrate the EU-MDR and ISO/DIS 14155:2018
- Understand the role of the Notified Body and Competent Authority
- Grasp the format and contents of the application, investigator’s brochure and clinical trials plan
- Determine informed consent requirements
Make sure you fully understand the EU-MDR’s and ISO/DIS 14155:2018’s clinical trials requirements — how they work together and how to make them work for you.
About the Author
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.
Who Will Benefit
- Sponsor’s R&D staff
- Principal investigator
- Regulatory affairs staff
- Clinical affairs/operations managers
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