CE MDR Risk Management File Generation

The EU Medical Device Regulation (MDR 2017/745) explicitly requires manufacturers to reduce risks "as far as possible" without adversely affecting the benefit-risk ratio. The scrutiny applied by Notified Bodies under MDR is significantly higher than under the previous MDD.

MedMI helps you build a CE MDR Risk Management File that stands up to this scrutiny. Our system forces structured documentation of Risk Controls (inherent safe by design, protective measures, and information for safety) ensuring explicit alignment with MDR General Safety and Performance Requirements (GSPRs).

Generate clear, defensible residual risk justifications and comprehensive traceability matrices required for your MDR Technical Documentation.