Clarity on Clinical Investigations
What You Need to Know About EU-MDR and ISO/DIS 14155:2018

Thursday, Sept. 19, 2019 • 1:30 p.m. - 3:00 p.m. EDT


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.

Webinar Takeaways:

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

Webinar plus USB Audio Recording/Transcript
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$487

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Webinar only
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$287

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24/7 Encore plus USB Audio Recording/Transcript
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$487

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24/7 Encore Presentation
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$287

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USB Audio Recording/Transcript
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$287

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Meet Your Presenter

Dan O’Leary

President
Ombu Enterprises, LLC

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.

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