Clinical investigations with medical devices, where to start? This half-day course will focus on:
- The basics of the medical device EU and US regulatory framework,
- ISO14155 standard
- Medical device definitions & classifications
- Medical device life cycle and the importance of clinical investigations
- The different stakeholders involved in device clinical investigations and their responsibilities.
At the end, you will receive a certificate for attendance and a copy of the course slides.
By the end of this TRIUM Training you should be able to:
- List the regulatory framework for clinical investigations with medical devices
- Explain the role of clinical investigation in the development of devices
- Identify the stakeholders involved and explain their role in clinical investigations with medical devices
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.