ISO 14971 Medical Device Risk Management Course
Our ISO 14971 course is delivered by highly qualified experts in an interactive and engaging format. This practical one-day course will give you the skills and tools to perform risk assessments and manage product and process risks using ISO 14971:2019.
£440.00 +VAT per delegate
Course Details
£440.00 +VAT per delegate
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What will I learn?
This training course will cover the following topics:
- The secrets of what your approved body is looking for in a risk management system.
- How to manage risk and the product lifecycle using ISO 14971:2019.
- Why Failure Mode Effect Analysis alone is not enough to pass an audit.
- The key links between product design and controlling your processes.
- Tool box to effectively manage and control risk.
This course is for anyone who works in the medical device industry and wishes to gain a better understanding of ISO 14971, risk assessment, and risk management for medical devices. This includes anyone involved in the design and development, production, or distribution stages, as well as auditors.
This course will give you a good practical understanding of Risk Management Systems and ISO 14971:2019. This will help you and your organisation to identify gaps in your risk management system as a basis for improvement – helping you to increase your regulatory compliance and system effectiveness. Our experienced trainers will also guide you through ISO 14971:2019 so that you have a good understanding of what your notified body is looking for the next time they audit you.
Build confidence. Sharpen skills. Audit with assurance.
The Audit Mentor service from QCS International is designed to support auditors who want to turn theory into confident, effective practice. Following your CQI & IRCA registered training, this service provides personalised, practical coaching to help you develop your auditing capability in real-world settings.
Delivered as a one-to-one or small group session, you will be accompanied by an experienced ISO audit professional who will mentor you through a live audit. You’ll receive hands-on support, constructive feedback, and expert guidance throughout the process—helping you refine your approach and gain confidence in your audit role.
What you’ll gain
• Live audit coaching during an on-site or remote audit
• Practical advice on audit structure, approach, and questioning techniques
• Guidance on audit format, evidence gathering, and reporting
• Real-time feedback to strengthen your audit skills and professional judgement
• Increased confidence and competence in conducting audits independently
How it works
• Half-day mentoring session
• Includes a pre-audit planning call to prepare objectives, scope, and approach
• Available for on-site or remote audits, offering flexibility to suit your organisation
BSI Standards
A copy of ISO 14971:2019 will be available to you during your training. QCS, as an authorised BSI Distributor, can sell you a full, licenced copy of the standard. As a training delegate we can offer you a copy at 25% off the current price. Simply add this when booking your course at checkout and we will send you a link to download your copy.
For this course you might want to purchase ISO 14971:2019.
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