Risk Management
Build ISO 14971-compliant risk management files that hold up to FDA and Notified Body scrutiny: hazard identification, controls, and benefit-risk justification.
Overview
Risk management files are often the weakest link in a submission. They are written under time pressure, copy hazards from prior products that no longer apply, and skim the benefit-risk justification that auditors actually read first.
We build the file fresh: hazard identification grounded in your device's actual use, risk analysis with defensible methodology, controls traceable to specifications, and a benefit-risk justification that withstands cross-examination.
Our Process
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1
Intended use & user analysis
Ground the risk file in the device's actual clinical use.
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2
Hazard identification
Systematic identification across foreseeable misuse, single-fault, and reasonably foreseeable use scenarios.
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3
Risk analysis
Severity, probability, detectability with documented methodology.
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4
Risk controls
Design, protective, and information controls with traceability to specifications.
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5
Benefit-risk justification
Defensible conclusion that survives scrutiny.
Frequently Asked Questions
Does this align with ISO 14971:2019?
Yes, including the 2020 corrigendum and FDA recognition specifics.
What about ISO/TR 24971?
Used as a guidance document throughout.
Does this cover AI/ML-specific risks?
Yes, model performance drift, dataset shift, and human-AI interaction explicitly addressed.
Can this support EU MDR submission too?
Yes, same file structure with EU-specific harmonized standard references.
Build the file that survives the first audit.
Tell us your device and submission timeline. We will return a risk management file plan within three weeks.
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