Risk management
Turn product risk into controlled design decisions
For medical software, AI-enabled technologies and software-driven devices, risk management must stay connected to development, clinical evidence, cybersecurity and post-market experience. MDRC builds that connection around ISO 14971.
Why it matters
A risk file is useful only when it influences the product
Risk management is often documented too late or maintained separately from development. This creates inconsistent hazards, controls and evidence across the technical documentation and makes changes harder to assess.
Guide development
Hazards and hazardous situations inform requirements, architecture, usability, cybersecurity and design controls.
Support the evidence
Risk controls are traceable to implementation and verification, while residual risks remain consistent with clinical evaluation.
Respond to change
Software updates, new vulnerabilities, complaints and post-market trends trigger proportionate reassessment and action.
One continuous system
Risk management connects evidence across the lifecycle
ISO 14971 provides the core process, but a credible implementation depends on reliable interfaces with the activities that define, test and monitor the device.
MDRC establishes these interfaces so new information is assessed consistently and the risk-management file remains aligned with the product and its regulatory claims.
How we help
A defensible process and documentation your team can maintain
We can establish risk management for a new device, strengthen an existing file or resolve inconsistencies identified during technical-documentation review, due diligence or conformity assessment.
Define the process
We establish responsibilities, criteria, methods and interfaces appropriate to the device, organisation and applicable markets.
Build the risk file
We develop the plan, analyses, control traceability, evaluations and report required for a coherent ISO 14971 file.
Connect the evidence
We align risk outputs with software, usability, cybersecurity, clinical evaluation, GSPR and verification documentation.
Maintain lifecycle control
We integrate change assessment and production and post-production information into ongoing risk review and updates.
Work with MDRC
Make risk management part of how your device is developed and maintained
Tell us about your product, development stage, existing risk documentation and target markets. We will define the right scope and a practical route to a complete, connected risk-management system.
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