Medical Devices STAR Programme
About this course
The Medical Device world is fundamentally different from the Pharmaceutical environment: different products and legislations, different concepts, different strategies: all requiring a specific approach during the entire development phase of the product.
Are you a starter in Clinical Research with Medical Devices? Are you an experienced CRA or a Junior Project Manager with limited experience in Medical Device Clinical Operations? In this 4-day STAR program, you will get all you need to know about Medical Device Investigations from start to finish.
Programme highlight
The courses included in the Medical Device STAR programme are selected to provide the essential competencies needed for you to work in the field of Medical Device Research. The programme is composed of the following courses:
- Introduction to Clinical Research with Medical Devices – eLearning
- Running Medical Device Studies
- ISO14155 Good Clinical Practice Training – eLearning
- Medical Device Regulations
These courses are organised twice a year, you can either follow them consecutively (in 1 week) or compose your own schedule over the 2 occasions.
Learning objectives
- Understand the world of Medical Devices
- Learn about the latest medical device regulation
- Learn about ISO 14155 in its latest version
- Understand the operational aspects of running medical device trials
Who should attend
This programme is designed for people with no or limited understanding of medical device investigations. During the 4 days, the expertise is gradually built up to make you an expert at the end. If you are a CRA of PM with pharma experience and want to run medical device trials, then this programme is perfect for you. Even if you have experience in medical device trials, the programme allows you to get the latest updates on regulations and best practices from expert trainers.
Competencies
This series of courses cover 89% of competencies that are needed to carry out Medical Device Clinical Investigation as described in the ECCRT Competency Framework
- Scientific Concepts & Research Design (2)
- Ethical & Participants Safety Considerations (5)
- Investigational Product Development and Regulation (6)
- Clinical Studies Operations (GCPs or ISO 14155) (9)
- Study and Site Management (6)
- Data Management and Informatics (2)
- Leadership and Professionalism (4)
- Communication (2)
- Teamwork (1)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained.
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