ISO14971:2019 documentation

To effectively manage risks associated with (IVD) medical devices, companies typically follow international standards and guidelines, such as ISO14971, which provide a structured framework for risk management in the medical device industry. This involves identifying potential hazards, assessing their risks, implementing risk controls, and monitoring the device’s performance in the market to ensure ongoing safety and effectiveness.

Our goal is to simplify compliance. Therefore, QRcompliance has developed intuitive templates for creating ISO14971:2019 compliant documents.

Template - Risk Management Procedure

Template - Risk Management Plan

Template - Risk Management FMEA

Template - Risk Management Report