Webinar:

Clinical Evidence for Medical Devices Under Regulation (EU) 2017/745

Sponsored by: NSF International

Focused on:

  • Regulation
  • Clinical Data

Date: 8 October

60

Time: 3PM London/10AM New York

Join this NSF International webinar in which expert, Dr. Kivia Pontes de Oliveira, describes Regulation (EU) 2017/745 with a special focus on the collection, generation and evaluation of clinical data for medical devices.

This includes a short introduction and general requirements on regulation and the definition of clinical data. She will also discuss potential routes to perform a clinical evaluation along with how to indicate, identify and generate clinical data.
At the end of this webinar Dr. Kivia will recap strategical steps on how you can start preparing to become compliant now.



Presented by

Dr. Kivia Pontes de Oliveira,

Consultant for Clinical Affairs – NSF International

Dr. Kivia Pontes de Oliveira is a Consultant for Clinical Affairs at NSF International.

She holds several years of professional experience in the fields of medical writing and clinical affairs. In the last year Dr. Kivia has evaluated clinical data and prepared clinical evaluations following the new clinical requirements for medical devices of class I to class III.


Key Learning Objectives

  • Better understand Regulation (EU) 2017/745
  • Discuss evaluation routes
  • Identify clinical data sources

Audience

  • Head of regulatory affairs
  • Regulatory Affairs Specialists
  • Heads of Research and Development
  • C Suite Employees
  • Senior Managers
  • Managers