Course description
Fundamentals of Risk Management for Medical Devices
Risk management is a complex but necessary process for medical device companies, and its complexity has only heightened with the introduction of more stringent regulatory requirements under ISO 14971 and the Medical Device Regulation (MDR). It is crucial to learn how to correctly modify your approach, so that you are harmonised with the new Regulations and can guarantee your compliance.
This online course will provide you with a complete overview of the key regulatory considerations for risk accompanied by the tools and techniques you can use to implement them, for both professionals new to the area and those who need an update on the latest developments. You will be able to cement this knowledge through an entire module on case studies based off the trainer’s own experiences, so you can practically apply the information you have learned.
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Suitability - Who should attend?
This course will be useful for personnel involved in risk assessment and risk management activities, and for those who are new to the industry and need a complete overview of the medical device regulatory framework in the EU. It will be applicable for professionals in:
- Regulatory affairs
- Quality assurance
- Product managers
- Design engineers
- Clinical staff
- Project managers
Outcome / Qualification etc.
- Understand the importance of ISO 14971 and how to apply it to your own processes
- Identify links between ISO 14971 and ISO 13485
- Improve your understanding of the risk requirements under the MDR and distinguish its differences from the MDD
- Develop your skills in risk management planning by learning about key methods for project management
Training Course Content
- Module 1: Key risk management regulations
- Module 2: The stages of risk management
- Module 3: Usability engineering - ISO EN 62366 1 & 2 2015
- Module 4: Case Studies
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5