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 provides structured fields for documenting risk-control hierarchy, residual-risk rationale and links to applicable GSPRs. Final applicability and adequacy must be reviewed by the manufacturer.

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