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Risk Management — ISO 14971
ISO 14971 risk management: hazard analysis, risk estimation and control, benefit-risk reporting and alignment with the MDR.
10 articles
FMEA applied to medical devices: a relevant tool, but often poorly used
A poorly filled FMEA table is more dangerous than a blank one: it simulates an analysis while the real risks go unexamined. Overly generic failure modes, unjustified ratings and unverified controls drain the tool of its substance.
Risk Management for Medical Software: IEC 62304 and ISO 14971 Together
IEC 62304 sorts software into three safety classes, from A (no injury or damage to health possible) to C (death or serious injury possible), while ISO 14971 covers the whole device: the notified body expects both approaches to be linked in the file.
Use-Related Risk Management: IEC 62366-1 and Its Articulation with ISO 14971
IEC 62366-1 identifies foreseeable use errors while ISO 14971 assesses and controls the resulting risks. Technical documentation that addresses usability through the generic FMEA alone remains incomplete.
ISO 14971:2019: key changes compared with the 2007 edition (EN ISO 14971:2012)
Method and acceptability criteria for overall residual risk set in the plan, clinical benefits integrated into the benefit/risk analysis and post-production data: three substantive changes set the 2019 edition apart from the 2007 edition (EN ISO 14971:2012).
Hazard Identification under ISO 14971: Method, Sources and Completeness
Clauses 5.2 to 5.4 of ISO 14971:2019 structure hazard identification: intended use and reasonably foreseeable misuse, safety-related characteristics, then hazards and hazardous situations. Vigilance data usefully enrich it. The notified body checks not the completeness of the list but the systematic nature of the approach.
Risk control measures: hierarchy, effectiveness and verification
Inherently safe design outranks protection, which outranks information: the order of the three levels is not negotiable. Clause 7.2 demands objective proof of each measure's effectiveness, and 7.5 requires checking that no measure introduces new hazards or worsens existing risks.
The risk management plan: required content and structural mistakes
Section 4.4 of ISO 14971:2019 expects a document of method and governance, not a collection of results. Pouring hazards and assessments into it produces a hybrid that is hard to audit and to keep up to date.
Risk estimation and risk evaluation: acceptability criteria and the risk matrix
Under ISO 14971, a risk matrix only holds if its acceptability thresholds rest on data rather than a copied template. Notified bodies look above all for the same effect scored 3 on one line and 5 on another with no justification.
End-of-life risk management review: when and how to conduct it
A serious incident, a novel complaint or a product change trigger an update of the risk management file: clause 10 of ISO 14971 requires tracing each review, which the notified body then checks at surveillance.
The MDR benefit-risk report: how to demonstrate that the benefits outweigh the risks
The most scrutinised section of the technical documentation collapses as soon as it settles for a claim without quantified evidence. Its conclusion must weigh quantified clinical gains against the dangers remaining after control, per ISO 14971.
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