Chip lifecycle / Standards and compliance / Medical / ISO 14971

ISO 14971: Medical devices: application of risk management to medical devices

The risk management process for medical devices across their whole life: plan, analyse, evaluate, control, judge the overall residual risk against benefit, review, and keep learning from production and post-production information. Regulators and the device standards rely on it, and its outputs feed design, verification, labelling and post-market surveillance.

This is a summary, not legal advice. Confirm every point against the official text before relying on it, and ask counsel whether it applies to a particular product, transaction, shipment or party.

Standards are the copyright of their publishers. These guides explain purpose, structure and practice in our own words and cite parts or clauses by number; obtain the standard itself from its publisher before you rely on any requirement.

When it applies

You are the manufacturer of a medical device or of medical device software, in any market.
Your chip, module or software implements a function a device maker relies on as a risk control, such as a monitor, a limit, an alarm path or an isolation barrier.
A device maker asks you for failure modes, failure behaviour or reliability data for its hazard analysis.
You build medical electrical equipment, where the general safety standard requires a risk management process of this kind.

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