Safety Cannot Be Retrofitted
Treating risk management as a 'paperwork exercise' after development is complete is the fastest way to trigger a 'Refuse to Accept' (RTA) or get stuck in endless deficiency loops.
The Traceability Gap
Risk controls that are proposed in documentation but never actually verified in the final product, leaving a critical gap for auditors to find.
Incomplete Scope
Failing to address crucial areas like Usability (IEC 62366), software anomalies, or cybersecurity threats in the risk assessment.
Static Documents
Creating a 'point-in-time' risk file that doesn't evolve, failing to meet the post-market and lifecycle requirements of modern regulations.
The Leanabl Insight
We view Risk Management not as a compliance burden but as a value-creation tool. A robust risk file is the most effective way to streamline development, reduce testing costs, and build a device that is inherently safer and more effective.
Comprehensive ISO 14971 Compliance
We execute the entire risk management process, from planning to final reporting, creating a file that stands up to the toughest auditor scrutiny.
Hazard Analysis (Top-Down)
We start by systematically identifying known and foreseeable hazards, the sequences of events that can cause them, and evaluating the potential resulting harms.
FMEA & Control Strategy (Bottom-Up)
We conduct detailed Design, Process, and Use FMEAs (DFMEA, PFMEA, UFMEA) to identify failure modes and define robust engineering and procedural controls.
Benefit-Risk Analysis
We perform a scientific evaluation of the overall residual risk against the anticipated clinical benefits, creating a defensible rationale for EU MDR and FDA compliance.
From Assessment to Audit-Ready File
Hazard Workshop
A collaborative session to identify and document all potential hazards and foreseeable misuse.
Analysis & Mitigation
We define clear engineering controls, risk mitigation measures, and the verification tests required to prove their effectiveness.
File Compilation
We compile all analyses and reports into a single, audit-ready Risk Management File (RMF).
Your Complete Risk Management File
Risk Management Plan (RMP)
Hazard Analysis (PHA)
FMEAs (DFMEA/PFMEA/UFMEA)
Risk Management Report (RMR)
Guaranteed Traceability
Why Trust Our Risk Experts?
Integrated Approach
We don't silo Risk. We link it directly to your Design History File, ensuring every control is tied to a design input and a verification test.
Cybersecurity Ready
We build cybersecurity threat modeling (AAMI TIR57) directly into your ISO 14971 process, preparing you for modern connected device requirements.
Lifecycle Mindset
We create living documents designed for easy updates, making Post-Market Surveillance (PMS) and annual reviews a seamless process.
Secure Your Safety Case.
Don't let a weak risk file jeopardize your approval. Let's build an audit-proof file together.
Start My Risk File Project