This is a professionally developed Medical Device training course which incorporates the Medical Devices Regulation (MDR), which became fully applicable in 2021, along with ISO 14155:2020 and Regulatory guidance from the FDA and MHRA. The Medical Devices Regulation (MDR) supersedes the previous Medical Devices Directive (MDD).
This highly interactive and engaging course enables the learner to develop knowledge and understanding of the Medical Device development process and how to remain compliant with all the relevant Regulations, Guidelines and Standards to gain marketing approval.
It is suitable for anyone currently working on Medical Device Clinical Investigations or those wishing to develop their knowledge, skills and understanding of Medical Devices and how to be compliant with the Regulations, Guidelines and Standards that govern their development.
- Become familiar with the Regulatory requirements governing Clinical Trials involving Medical Devices.
- Consider what makes an effective QMS
- Develop an in-depth knowledge and understanding of the content and structure of the Medical Device Regulation (MDR) and ISO 14155.
- Understand the responsibilities of each of the Medical Device stakeholders considering ISO 14155 and consider practical implementation of these Guidelines and Regulations.
- Understand the process for gaining Medical Device approval and bringing that device to market.
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