Strengthen ISO 14971 risk management with traceability
In medical device development, risk management isn’t only about identifying and controlling risks. It’s about being able to trace every decision, control measure, and outcome, right back to its origin.
That’s the foundation of true compliance with ISO 14971 and IEC 62304, and it’s what separates a compliant process from a truly controlled one.
Understanding the ISO 14971 risk management process
The ISO 14971 standard defines a structured process for identifying, evaluating, and controlling risks throughout the medical device lifecycle. It covers every essential step, including:
Risk analysis
Risk evaluation
Risk control implementation
Residual risk evaluation
Risk management review
Production and post-production activities
Each step builds on the previous one, forming a continuous loop of review and improvement. But for this process to be effective, every element must stay connected. Without traceability, those links break and teams lose the ability to prove how risks were identified, mitigated, and verified.
Integrating software risk management with IEC 62304
Modern medical devices increasingly rely on software, which introduces its own layer of complexity. That’s where IEC 62304 comes in.
This standard defines requirements for software development and risk control, including:
System and software requirements
Software system testing
Software-specific risk control measures
Just like with hardware, these activities must be fully traceable. Software evolves rapidly, and even small updates can change the risk profile of a device. Maintaining live links between system requirements, risks, and test results ensures that your safety measures remain valid as your software changes.
Why traceability is essential for risk management
Traceability is what holds your entire risk management process together. It gives you a clear view of:
Which risks have been mitigated
What control measures are in place
How each control has been tested and verified
When risks, requirements, and verification activities are linked, teams can quickly see the impact of changes and maintain consistency throughout the development lifecycle.
The best practice is to link risk controls directly to product requirements, defining them as safety requirements. Since requirements are already tracked, verified, and change-controlled, this connection keeps your risk management aligned with your evolving design.
How Matrix Req improves ISO 14971 traceability
This is where Matrix Req helps medical device teams simplify compliance and maintain high-level traceability.
Our ALM platform connects every element of your risk management process in one centralized space. With Matrix Req, you can:
Create live links between risks, requirements, tests, and outputs
Use real-time dashboards to track risk control activities
Receive automatic alerts when changes impact traceability
This real-time connectivity gives you visibility across the entire lifecycle: from design and testing to post-production monitoring. It helps you manage risks proactively and ensures that your ISO 14971 and IEC 62304 documentation always stays accurate and audit-ready.
Building stronger medical device compliance with connected risk management
Risk management is more than a checklist of steps. It’s a continuous, traceable process that connects safety, quality, and performance from concept to market. By integrating traceability into every stage of risk management, medical device teams can make confident, data-driven decisions and maintain full control as their designs evolve.
With Matrix Req, those connections are built in from day one, helping you achieve compliance, strengthen your documentation, and deliver safer, more reliable medical devices.