Quality Risk Management and ISO 14971:2019 

Course Content

• ISO 14971: 2019 – detailed analysis of the requirements of the standard.
• Risk Management for CE Marking of Medical Devices and the relationship between ISO 14971:2019 and EN ISO 14971:2012.
• Identifying possible hazards.
• Estimating the associated risk 
• Risk Review and Risk Reduction.
• Understanding the difference between AFAP and ALARP.
• Risk Management Technique Hazards - FMEA
• Benefit-Risk analysis.
• Risk Management Reporting.
• Production and Post Production Information.
• Disclosure of Residual Risk.
• How to apply Risk Management to the Product Lifecycle.
• How to apply Risk Management to all aspects of Quality and Production

Programme Outcomes   

Participants  will achieve the following learning outcomes from the programme;

• Have an appreciation of  the updated requirements of ISO 14971: 2019.
• State the requirements for Risk Management for CE Marked Medical Devices.
• Identify the correct use of the AFAP and ALARP approaches.
• Identify and quantify risks associated with Medical Devices.
• Apply risk assessment technique- FMECA
• Describe how to perform Benefit-Risk analysis.
• State the requirements for Production and Post Production information
• State the requirements for Disclosure of Residual Risk.
• Describe the Life Cycle Approach to Risk Management.