Medical Devices Risk Management ISO 14971

Face-to-face Instructor Led Courses, Quality Assurance, ISO

What Is Medical Devices Risk Management ISO 14971 Training?

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.

Course 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
- 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.


Available onsite or nationwide at any of over 50 centres, see below our open course availability. Alternatively, call 0844 335 8882.


The Medical Devices Risk Management ISO 14971 course will be accredited to the latest in recognised certificating award. All successful delegates will also receive an Xyz certificate of attendance. Enrolled subscribers of the National Training Card will also have any certificate, qualification and/or ID card (where applicable) automatically added to their member account.

Open Courses & Public Events

Our Medical Devices Risk Management ISO 14971 training public event calendar has more than open course training dates taking place across the UK. Search and book securely online and receive an immediate confirmation together with full joining instructions, your VAT invoice and a receipt of payment. You are also able to make an enquiry and receive our formal quotation. Lowest price guaranteed.

More Information

We train in excess of 100,000 delegates per year. For more information, please make your enquiry using the form below. The XYZ Training Group Customer Charter ensures that all enquiries are responded to the same day.

Course Availability

In addition to a comprehensive Medical Devices Risk Management ISO 14971 open course schedule, training is also available on client premises or at one of our training venues as a private course - provided minimum delegate numbers are achieved. Whatever your requirement, start by completing the form below and we'll send you the full course information and a quotation based on your requirements.

Make A Medical Devices Risk Management ISO 14971 General Enquiry Here

Complete the form below and we'll send you some training options and / or a quote by return. Please only use this form if you are interested in Medical Devices Risk Management ISO 14971 courses. For all other enquiries, please use the general contact page, refine your search above or call us on 0844 335 8882.

Medical Devices Risk Management ISO 14971 Training Enquiry

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Medical Devices Risk Management ISO 14971
Part of our ISO range of training courses

Course Information

  • Course Duration 2 days
  • Max Class Size 12

  • All prices exclude VAT. Discounts available for larger groups & for corporate clients.
Our Medical Devices Risk Management ISO 14971 Training Courses

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