ISO 14971:2019 Risk Management for Medical Device – PFMEA Live-Online (2-Day)
Learn the application of the FMEA approach to ISO 14971:2019 Application of Risk Management to Medical Devices, and be able to define the use of DFMEAs as a process within your organization. This course provides an overview of the steps of the FMEA process and how it is managed as a process.
- Interpret ISO 14971 requirements
- Define Risk Management Terminology
- Understand Process and Stages
- Apply Risk Management to your company
- Application of FMEA approach to ISO 14971:2019
- Manufacturing Processes and Risk Control (PFMEA)
- Use of PFMEAs as a process in the organization
This seminar is designed for those responsible for introducing new medical devices or new manufacturing processes and systems including quality managers, quality engineers, design developers, and others who are responsible for the medical device development and improvement.
Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating jurisdictions and organizations expanding their market reach to jurisdictions participating in ISO 13485:2016 will also benefit from this course.
- Application of FMEA approach to ISO 14971
- Use of PFMEAs as a process in the organization
- Overview of the steps of the FMEA Frameworks for Managing Risk
- Manufacturing Processes and Risk Control (PFMEA)
- Process Requirements
- Process Flow Diagram
- Process Failure Modes
- Potential Causes
- Process Controls
- Risk Evaluation
- Risk Treatment
- Monitoring and Review