Join us live online for two half-day sessions on February 22-23, 2023 12:00p - 4:00pm ET.

During this virtual training, our hand-picked experts will share details about the changes to the standard and provide insight on other key topics around information security, the changing landscape, and new threats.

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Course Details

Understanding the Clinical Evaluation Consultation Process (CECP) & Expert Panel Roles

Course Area

Medical Devices

Availability

Available for 90 days after enrollment

Approximate Course Run Time

1 hour

Continuing Education Units

0.1

Course Fee

No charge

E-learning content is available on demand!

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Course Details

Overview

BSI Medical Devices webinar provides the required information to manufacturers of class III implantable, and class IIb active rule 12 administer or remove medicinal substances (ARMS) devices of the new clinical evaluation consultation procedure (CECP) in accordance with Article 54 of the Medical Device Regulations EU 2017/745.

Key takeaways and learning objectives

This webinar will cover: 

  • Introduction to the EU Expert Panels
  • Article 54
  • The CECP Process
  • Preparing your submissions
  • Article 54.3
  • Article 61 (2)
  • BSI experience of CECP

Presenter information

Speakers - Richard Holborow/Sheila Walsh, Head of Clinical Compliance/Clinical Regulatory Lead

Live Online Classes

Certified, convenient, and interactive, with no travel costs.

Private Class

Interested in a private or customized version of this course? Request a quote.

Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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