Risk Management Templates

Build an adaptive & ISO 14971:2019-compliant Risk Management system for all your medical devices

Risk Management Templates

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

Complete coverage of essential documents in one package

  • 24 fill-in templates
  • Produce integrated and adaptable Risk Management Systems with clear, compliant documentation
  • Develop risk acceptability frameworks and evidence based risk estimation criteria
  • Perform a preliminary hazards analysis using fault and non-fault conditions
  • Develop and maintain a traceability matrix to enable efficient audits and regulatory reviews
  • Complete 360-degree package for full ISO 14971:2019 compliance
  • Complements our Risk Management Training Course

In more detail

Develop an effective Risk Management System across your entire medical device portfolio.

  1. These templates are designed for QA/RA professionals with some understanding of medical device Risk Management. It is also suitable for company founders and members of early stage start-ups who have undergone our EU MDR Risk Management Training Course.

  2. A set of detailed document templates including guidance text. Address all major aspects of ISO 14971:2019 including Risk Management Plans, Files, Reports, PHA, FMEA, risk acceptability, risk estimation, risk control, overall residual risk, post-production information and more.

  3. Independently produce and correctly document a Risk Management System for all your medical devices regardless of type or class.

  4. No - following purchase, the templates are yours to keep without any additional payments.

  5. The templates open with standard Word Processing (e.g. Microsoft Word), Spreadsheet (e.g. Microsoft Excel) and PDF applications. They require no activation or access codes.

Download today

You can download and use your document templates immediately after purchase.

Risk Management Templates

  • 24 fill-in templates

Build an adaptive & ISO 14971:2019-compliant Risk Management system for all your medical devices

  • Produce integrated and adaptable Risk Management Systems with clear, compliant documentation
  • Develop risk acceptability frameworks and evidence based risk estimation criteria
  • Perform a preliminary hazards analysis using fault and non-fault conditions
  • Develop and maintain a traceability matrix to enable efficient audits and regulatory reviews
  • Complete 360-degree package for full ISO 14971:2019 compliance
  • Complements our Risk Management Training Course
  • 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

  1. After payment you will get access to our Resources platform where all your purchases are stored.

    Invoices can be found in your Settings > Billing section.

Do you have any questions to ask our team?

Contact us