- Understand the structure, key requirements & terminology of ISO 14971:2019
- Learn how to correctly apply Risk Management principles to the entire life cycle of a device
- Gain complete understanding of each stage of the Risk Management process
- Confidently produce all essential documents and efficiently manage updates
- Learn how to integrate Risk Management with QMS, PMS & broader regulatory activities
- Identify opportunities for product improvement & competitive advantage
- Also available to purchase in our package offers
EnableCE Learn Risk Management Training Course
Learn how to build & maintain your ISO 14971:2019-compliant Risk Management System
Also included in our discount package offers
- Risk Management Plus / £790 £595
Course overview
- 57 videos
- 34 documents
- Understand the structure, key requirements & terminology of ISO 14971:2019
- Learn how to correctly apply Risk Management principles to the entire life cycle of a device
- Gain complete understanding of each stage of the Risk Management process
- Confidently produce all essential documents and efficiently manage updates
- Learn how to integrate Risk Management with QMS, PMS & broader regulatory activities
- Identify opportunities for product improvement & competitive advantage
In more detail
Develop an entire Risk Management system for all your medical devices.
About this course
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This training course is designed for people who want to produce complete Risk Management Systems in-house. It is suitable for QA/RA professionals with existing knowledge of the EU MDR and company founders during early stage product development.
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Instant, on-demand and unlimited access to videos and downloads along with updates and additions to the existing training material.
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This course is presented by the CEO of Mantra Systems, Dr Paul Hercock, who has extensive knowledge of medical device Risk Management. He is an experienced presenter of clinical and technical training.
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Confidently build a complete Risk Management System from start to finish for your entire portfolio of medical devices.
About our courses
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Our training courses are broken up into chapters and short, streamable videos which save your progress automatically. Where relevant, downloadable documents are included to support your learning.
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All our training courses are on-demand and can be completed to your schedule in the comfort of your own workspace. You won't have travel or accommodation costs, or any other expenses usually incurred whilst away from your office.
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You will have unlimited access to your selected training under a Single User Licence. If we update or add anything to the training course material, we will let you know by email. If you require access for multiple team members, please contact us about our Multi User Licences.
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Our EnableCE platform offers training courses and technical document templates that work together to provide a great regulatory support package. Mantra Systems also offers a range of consulting services, MDR resources such as free White Papers, industry focused articles and an EU MDR Compliance Guide.
Start today
You can start your training course immediately after purchase.
Risk Management Training Course
- 57 videos
- 34 documents
Learn how to build & maintain your ISO 14971:2019-compliant Risk Management System
Single one-off payment £495
Package offers
We also offer reduced price packages of related training courses and templates.
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Risk Management Plus
- Risk Management Training Course
- Risk Management Templates
Prices shown exclude UK/EU VAT
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For all purchases, you will receive a receipt by email confirming payment.
Templates & tools:
You will receive an email containing a link to download your files.Training courses:
You will go through the account set up process to access the training course platform.Training course + template package:
You will go through the account set up process to access the training course platform. Within one working day you will receive an email to download your template(s).
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