This is a professionally developed, interactive and engaging online Medical Devices training course (which incorporates the recent ICH E6 R2 update implemented in June 2017, along with ISO 14155 and the newly updated ISO 13485).
It is suitable for anyone carrying out or involved in clinical research with medical devices and will provide individuals with official certification in Medical Device Directive.
- Become familiar with the requirements of ICH-GCP for clinical trials.
- Medical Devices overview, understand the role of clinical studies in the development of medical devices.
- Develop in depth knowledge and understanding of the content and structure of the Medical Device Directive and ISO 14155
- Understand Quality Management systems for medical devices/ISO 13485 which was updated in 2016.
- Review the responsibilities of each of the medical device stakeholders in light of ISO 14155/13485
- Practical implementation of the Medical Device Directive/GCP.
All prices include VAT at 20%