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.

Technical Documentation File template, compliant with MDR 2017/745. Seamlessly aligned with Annex II, it ensures clarity, completeness, and compliance in each section. Tailored immersion with "HealthGuard BPX-2000" device blueprint. Expert-crafted, time-saving, and success leading.

Access a complete framework/template for documenting your GSPRs in accordance with Annex I of MDR 2017/745. For each GSPR: access a list of standards, a list of expected documents and a pre-written methodology. GSPRs are the basis for documenting your medical device's compliance with MDR 2017/745. Use this template as a guide from the start of your project. 77 pages, available for immediate download

Our comprehensive checklist provides you with all the mandatory regulatory requirements for medical device manufacturers. Not only does it outline these requirements, but it also offers two categories that will help you effectively implement them. For each requirement, we provide a method that explains how to incorporate it into your system, complete with concrete examples

Access a complete framework/template for documenting your GSPRs in accordance with Annex I of IVDR 2017/746. For each GSPR: access a list of standards, a list of expected documents and a pre-written methodology. Use this template as a guide from the start of your project. 45 pages, available for immediate download