ISO 14971 - Application of Risk Management
ISO 14971 Application of Risk Management to Medical Devices Overview - Virtual Training
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Course Duration: 2 Days
This two-day seminar addresses all of the elements of the ISO 14971:2019 Application of Risk Management to Medical Devices, and defines it as a process within your organization. It provides an overview of the six steps of the Risk Management process and how it is managed as a process.
- Explore the specifics of ISO 14971:2019, the Application of risk management to medical devices.
- Provide a hands-on approach to the medical devices process and its relationship to program deliverables and status reporting.
- Provide the competencies needed to introduce new products and processes smoothly with known risks minimized.
- Principles for Managing Risk
- Framework for Managing Risk
- Process for Managing Risk
- Risk Assessment
- Risk Analysis
- Risk Identification
- Risk Analysis Tools
- FMEA Risk Management
- Risk Evaluation
- Risk Control (treatment)
- Monitoring and Review
Those who have direct responsibility for introducing new medical devices and/or a new manufacturing processes and systems would benefit from this seminar. This includes: program/product managers, quality managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical devices development and improvement.
Each participant will receive a seminar manual and a workbook including all team breakout exercises.
No prior knowledge is necessary. However, a mix of students with knowledge of product design & development and/or manufacturing and basic Quality Assurance concepts is preferred.