This one-day intensive course enables greater understanding of the impact that ISO 14971:2019 has on the decision-making process when manufacturing medical devices.
It helps medical device professionals understand how ISO 14971:2019 can improve their business and risk management efforts.
This course is designed to provide you with an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing, and lifecycle of medical devices. It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard and the MDR 2017/745. Practical activities throughout the day will give you the opportunity to apply your skills, implementing risk management activities so that these can be embedded within the organization on completion of the course.
Who should attend?
This course is ideal for you if you’re in QA/Regulatory/Engineering/Manufacturing role involved in medical device design, development, and manufacturing.
Upon completion of this training, you will be able to:
- Define risk management terminology
- Explain how risk management relates to the product lifecycle
- Outline the stages of the risk management process
- Define the key deliverables of the risk management process
- Apply risk management principles within your organization
- Identify the links between ISO 14971:2019, ISO 13485:2016, MDR 2017/745 and the IVDR 2017/746
How will I benefit?
This course will help you to:
- Identify the key requirements of ISO 14971:2019
- Interpret and communicate the key requirements and expectations of ISO 14971:2019 to your organization
- Gain knowledge of how ISO 14971:2019 links to ISO 13485 and the regulations; MDR 2017/745 and IVDR 2017/746
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
- Why is risk management important?
- Module 1: Terms and definitions
- Module 2: Risk management and regulatory requirements
- Module 3: Risk management and the EU MDR and IVDR
- Module 4: Application of risk management to medical devices
- Module 5: General requirements for risk management systems
- Module 6: Risk analysis and risk evaluation
- Module 7: Risk control
- Module 8: Evaluation of overall residual risk, production and post-production ac
- Module 9: Review and summary