After months of intense developing of a To Health e-learning platform, which is base for materials developed within the project, we would like to introduce a project e-learning platform, based on Open Source e-learning software. We put a lot of effort to deliver user friendly system, that can help expand the knowledge of, inter alia, about Medical Devices EU regulations.
To Health course objectives are:
- Gain an overview of the European regulatory framework for medical devices, learn requirements applicable before devices may be placed on the market and how to comply with the current pan-european registration requirements.
- Understand requirements applicable in the medical device design and development process as well as requirements applicable throughout the whole device lifecycle in order to maintain compliance in all lifecycle phases.
- Acquire more in-depth knowledge of key points for medical device design including risk management, usability engineering and clinical evaluation.
- Learn how to comply with the medical device quality system requirements applicable.
- Understand and comply with the medical device vigilance system and post-market requirements.
- Know and identify the different groups of biomaterials and learn about their applications.