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Subscribe NewsletterProper Use of Risk Management Tools for ISO 14971 Medical Device Safety
Product Id
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600231
Overview: In this presentation we will use examples of the use of the tools for medical device risk management to complete the risk management process for a sample medical device.
During the presentation we will refer to the risk management standard ISO 14971 and its requirements. We will give examples for completing the documentation requirements of the standard. The presentation is intended to give practical information on implementation of the requirements of the standard and correct many mis-applications.
During the presentation we will refer to the risk management standard ISO 14971 and its requirements. We will give examples for completing the documentation requirements of the standard. The presentation is intended to give practical information on implementation of the requirements of the standard and correct many mis-applications.
Why Should You Attend: There are widespread misuses of risk management tools in application of ISO 14971 medical device risk management resulting in potential wrong estimates of risk for medical devices. This is especially true in the use of the reliability tool, Failure Modes and Effects Analysis (FMEA), the most widely used tool in risk management. Even experienced personnel have misunderstandings in this area and would benefit from this presentation.
Areas Covered in the Session:
- Requirements for risk traceability summary
- Examples of risk traceability summary usage
- Use and misuse of Failure Modes and Effects Analysis
- Examples of correct FMEA use
- Fault Tree Analysis (FTA) and probability of occurrence of harm
- Examples of correct use of Fault Tree Analysis
Who Will Benefit:
- Risk Managers
- Quality Engineers
- Process Engineers
- Design Engineers
- Quality Managers
- Regulatory Affairs
- Other Risk Management Team members
- Internal and External Auditors