Definition
What is the ISO 13485 standard?
The ISO 13485 standard defines the requirements of a quality management system specific to the medical device industry. Published in 2016 (with Amendment 11:2021), it is the international benchmark used by manufacturers, distributors, and suppliers across the medical device supply chain.
Unlike ISO 9001, ISO 13485 emphasises medical device lifecycle control: design, manufacture, distribution, post-market surveillance, risk management (ISO 14971), and regulatory compliance (FDA 21 CFR Part 820 / QMSR, EU MDR 2017/745, MDSAP, Health Canada).
ISO 13485 certification is required by virtually every market: the FDA in the US (now formally aligned with ISO 13485 through QMSR), the EU through MDR/IVDR, Health Canada, Japan through PMDA, and Australia through TGA. It is the baseline quality framework for global medical device commercialisation.
Who is ISO 13485 for?
The standard applies to medical device manufacturers, contract manufacturers (CMOs), distributors, sterilisation services, and component or software suppliers in the medical device supply chain.
Why get certified?
ISO 13485 certification is required to commercialise medical devices internationally, is the baseline for FDA QMSR alignment, simplifies notified body audits under EU MDR/IVDR, and structures rigorous traceability and post-market surveillance.
Avg. timeline
9 to 18 months
