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Essentials of European Medical Device Regulatory Affairs

The Organisation for Professionals in Regulatory Affairs
Course summary
1 day
English
Online courses

Course description

Essentials of European Medical Device Regulatory Affairs

This course provides an opportunity that on-the-job learning doesn't: network and learn from a variety of experts including your fellow participants. By attending this course, you will gain a basic understanding of the European medical device regulatory requirements and how to comply with them.

Suitability - Who should attend?

Suitable for

This course is designed for those:

  • Regulatory affairs professionals who require a comprehensive overview of medical devices
  • Who work in functions allied to medical device regulatory affairs (such as marketing, medical, quality, packaging and legal)
  • From related professions (law, pharmaceutical manufacturing, marketing and sales, healthcare, administration, project management)
  • Those who work in regulatory authorities and those in the regulatory sector

Outcome / Qualification etc.

Benefits to participants

  • Develop a broad understanding of the regulatory affairs profession within the medical devices industry.
  • Build a network to support the rest of your career
  • Meet and learn from experts in the field

Training Course Content

  • Introductions
  • Module 1: What is a Device?
  • Module 2: Who is who
  • Module 3: Legislation
  • Module 4: Classification of devices
  • Module 5: Conformity Assessment
  • Module 6: Device Labelling
  • Module 7: Clinical considerations
  • Module 8: Post Marketing

About provider

The Organisation for Professionals in Regulatory Affairs

The Organisation for Professionals in Regulatory Affairs (TOPRA)

The Organisation for Professionals in Regulatory Affairs (TOPRA) has encouraged excellence in the area of regulatory affairs for pharmaceuticals, veterinary medicines and medical devices since 1978. TOPRA's mission is to represent and promote the profession of healthcare regulatory affairs globally....


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Contact info

The Organisation for Professionals in Regulatory Affairs

3 Harbour Exchange, 6th Floor
E14 9GE London

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