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.
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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
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