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Icologiq Knowledge ยท Standard
ISO 14971
The international standard defining a systematic process for identifying, evaluating, controlling and monitoring risks associated with medical devices throughout their lifecycle.
ISO 14971
Also known as:
ISO 14971:2019, medical device risk management
At a glance
Definition
ISO 14971 describes a structured risk-management process for medical devices, including risk analysis, evaluation, control, assessment of residual risk, production and post-production information, and ongoing review.
Why it matters
ISO 14971 allows Icologiq to connect the Risk module to MedTech buyer concerns without positioning the platform as a substitute for specialist regulatory expertise.
MED-002
The international standard defining a systematic process for identifying, evaluating, controlling and monitoring risks associated with medical devices throughout their lifecycle.
ISO 14971 describes a structured risk-management process for medical devices, including risk analysis, evaluation, control, assessment of residual risk, production and post-production information, and ongoing review.
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