Chip lifecycle / Standards and compliance / Medical

Medical: standards and compliance

Chips, modules and software inside medical devices: a medical quality system, risk management across the life of the device, a software lifecycle, electrical safety and essential performance, usability engineering, security of health software, and the regulatory routes to market.

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.

Guides in reading order

ISO 13485 Quality management, certificationThe quality management system standard for organisations that design, make, install or service medical devices, or supply parts and services to those that do. It is the basis of quality system audits in the EU, in a single audit programme several regulators share, and, by reference, in the US Quality Management System Regulation.
ISO 14971 Functional safety, customer or contractThe 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.

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