Risk Management Templates

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

Single one-off payment £295

Complete coverage of essential documents in one package

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

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

Who are these templates suitable for?

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.
What is included?

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.
What will they enable me to do?

Independently produce and correctly document a Risk Management System for all your medical devices regardless of type or class.
Are there any recurring payments?

No - following purchase, the templates are yours to keep without any additional payments.
What are the file formats?

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.

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

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

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

Prices shown exclude UK/EU VAT

What happens after I've paid?

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.