Course Description
Risk Management can be a very complex process. ISO14971:2007 has been written to align it with the product development lifecycle and integrate into the manufacturers existing processes. This course will provide the delegate with the tools necessary to interpret ISO14971 and integrate risk management within their organization. It is a practical, workshop based course aimed towards accelerating the delegates' understanding through using focussed examples and stimulating the delegates' thought processes in relation to risk management within their organizations.
The course takes you through the typical phases of risk management and provides the delegate with the necessary practicalities of implementing risk management within their organization. It starts off by explaining the risk management plan, the mechanisms used in order to research information associated with hazards, their probability and severity. The course guides the delegate through the methods of accepting risk and transferring awareness of risk controls into areas such as manufacturing, the supply chain, clinical follow-up and product management.
The course provides the delegate with the mechanism for integrating risk management into daily organizational processes and gives guidance on how to keep risk management "alive" within their business.
Who Should Attend?
Various professional groups, including:
- Regulatory affairs professionals
- Quality assurance professionals responsible for design and/or manufacturing
- Design engineering and market managers responsible for medical devices within market processes
- Clinical and product management teams.
Benefits to Your Business
Medical Device manufacturers are expected to understand risk. This course will help you to understand the best way of integrating risk management into your organization and give you the tools and techniques necessary to ensure the risk management process effectively meets your requirements and the requirements of international regulators.
Course structure
- Overview of ISO 14971 and its use in the product development lifecycle
- Definitions and terms
- The product development process
- The risk management plan
- Medical device determining characteristics and hazards
- Sources of information
- Harms and hazards
- Fault tree analysis
- Ishikawa diagrams
- FMEA
- Risk acceptability, control plan and transfer process
- Lifecycle of risk
- Evaluating the effectiveness of the risk management process
- Application of ISO 14971:2007 to ISO 13485:2003
- The difference between ISO 14971:2001 and ISO 14971:2007
Further Information
Fee: Two-day course including refreshments, lunch and course notes
Attendance on this course will provide delegates with 16 CPD points.
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