€200

Risk Management Template Bundle

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5 Files

A bundle of risk management templates & guides that include: - Risk Management Procedure (.docx) - Risk Management Plan (RMP) (.docx) - Risk Management Report (RMR) (.docx) - Benefit-Risk Analysis Template (.docx) - Risk Analysis Tool (.xslx) - IEC 62366-1 & ISO 14971 Usability & Risk Management Annex (.pdf)

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Here is some feedback!

"Very insightful guidance on MDR and the Risk Management File."

Dan Bantz

Technology Manager | MBA in Operations and Technology

"I want to thank for every thing specially for risk assessment box."

Lauren Ghazale

Regulatory Affairs & Quality (QARA)

"Love this"

Justyna Czajkowska

R&D Celon Pharma Ltd

Why should I get the Risk Management bundle?

✅ Having all our documents ensures consistency and traceability in your risk management.

✅ Save €77 (approx. discount of 30%.) compared with purchasing all documents individually

What's inside the Risk Management bundle?

€79

Risk Management Procedure (.docx)

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1 file

A risk management procedure that complies with the requirements of ISO 14971 and also links the regulatory requirements for clinical evaluation and post-market surveillance of MDR 2017/745. You will find a series of flowcharts in this procedure that you can implement directly 21 pages, digital download

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€59

Risk Management Plan Template (.docx)

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1 file

A plan that meets the requirements of ISO 14971. Flowcharts, matrices and full methodology explained. This RMP template will provide you with a framework to complete your risk management plan according to ISO 14971:2019 (§4.4) and MDR 2017/745. 37 pages, digital download

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€69

Risk Management Report & Benefit-Risk Analysis Template (.docx)

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1 file

A risk Mangement Report, allows you to present your risks with a set of pre-designed tables and conclusions. It also contains the methodology & worksheet for establishing a risk/benefit ratio. Both in a single document. 55 pages, digital download

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€35

Hazard Traceability Matrix - Excel Tool (.xslx)

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1 file

An easy to use, semi-automated tool to help you comply with ISO 14971:2019 and to make a bridge with post-market surveillance. Excel file (.xlsx) semi-automated

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€35

IEC 62366-1 & ISO 14971 Usability & Risk Management - Annex

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1 file

An annex that will allow you to understand the relationship between IEC 62366-1 & ISO 14971. This annex will allow you to quickly understand and master the terms related to medical devices user error, understand the different scenarios and possible combinations, and know how to categorize risky usage situations.

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