Medical Devices Risk Management ISO 14971
Objectives
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. 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.
Who Should Attend:
This course would benefit regulatory affairs professionals, quality assurance professionals responsible for design and/or manufacturing, design engineering and market managers responsible for medical devices within market processes and clinical and product management teams.
Agenda
- 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
- 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.
Venue:
Available onsite or nationwide at any of over 50 centres, see below our open course availability. Alternatively, call 0844 335 8882.
Accreditation:
The Medical Devices Risk Management ISO 14971 course is accredited by the appropriate governing body and supported by certification and credit card sized ID cards produced by XYZ Training Group - the UK's largest dedicated Quality Assured training organisation.
More Information:
For more information, please make your enquiry using the links below or call us on 0844 335 8882. XYZ Training Group customer charter guarantees that all enquiries are answered within 24 hrs.
Course Availability:
Available on client premises as an in-house course or at one of training venues, provided minimum delegate numbers are achieved. Please complete the enquiry form here or contact us on 0844 335 8882. Unfortunately, this course is currently unavailable as an open training course.


Course Duration:
2 days
Maximum Class Size:
12
Price Guide:
Available On Request
Discounts For Larger Groups
All Prices excl VAT. Prices may vary
depending upon demand and availability.
Availability:
Available as a private course or at any of over 50 venues. Please make your enquiry here

Private Courses
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