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)

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

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

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

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

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.

How to Integrate Risk Management Activities in Design & Development? This short guide, illustrated with concrete diagrams, will help you quickly understand how to place risk management at the heart of your Design & Development activities.

This guide provides a clear, visual breakdown of Risk Management for medical devices in line with ISO 14971. It simplifies core concepts like hazard, risk, and residual risk using practical examples and illustrations (yes, with sharks). → Understand how risk is built (P1, P2, severity...) → Learn how to control and document it, risk acceptability concept.. 35 pages. 4 Part. Instant download