- 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 package offers
EnableCE Build Risk Management Templates
Build an adaptive & ISO 14971:2019-compliant Risk Management system for all your medical devices
Also included in our discount package offers
- Risk Management Plus / £790 £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.
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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.
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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.
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Independently produce and correctly document a Risk Management System for all your medical devices regardless of type or class.
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No - following purchase, the templates are yours to keep without any additional payments.
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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 technical documents 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
Single one-off payment £295
Package offers
We also offer reduced price packages of related training courses and templates.
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Risk Management Plus
- Risk Management Templates
- Risk Management Training Course
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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