Risk Management Systems

Learn how to build & maintain your ISO 14971:2019-compliant Risk Management System

Risk Management Systems

Single one-off payment £295

Buy now

Also included in our discount bundle offers

  1. Risk Management Plus / Full price £590 Discounted bundle price £445
  2. Technical Documents Master / Full price £885 Discounted bundle price £595

Course overview

  • 44 videos
  • 30 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

  1. 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.

  2. Instant, on-demand and unlimited access to videos and downloads along with updates and additions to the existing training material.

  3. 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.

  4. Confidently build a complete Risk Management System from start to finish for your entire portfolio of medical devices.

About our courses

  1. 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.

  2. 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.

  3. 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.

  4. Our EnableCE platform offers online video courses, technical document templates and White Papers & guides that work together to provide a great regulatory support package. Mantra Systems also offers a range of consulting services, MDR resources such as industry focused articles and an EU MDR Compliance Guide.

Start today

You can start your training course immediately after purchase.

Risk Management Systems

  • 44 videos
  • 30 documents

Learn how to build & maintain your ISO 14971:2019-compliant Risk Management System

  • 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 bundle offers

Single one-off payment £295

Buy now

Bundle offers

We also offer reduced price bundles of related training courses and templates.

  1. Risk Management Plus

    Full price, bought separately £590

    Discounted bundle price £445

    Buy now

  2. Technical Documents Master

    Full price, bought separately £885

    Discounted bundle price £595

    Buy now

Prices shown exclude UK/EU VAT

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