Overview
ISO 13485 is the international standard for a quality management system specific to medical devices – covering design controls, risk management, and traceability across a product’s lifecycle. It’s closely related to ISO 9001 but stricter on documentation and change control, since a defect in a medical device carries different stakes than one in ordinary software.
Why it matters
Regulators in most markets, including the FDA and the EU, expect a QMS aligned with ISO 13485 as part of clearing a medical device – including SaMD – for market. Retrofitting a QMS onto software that was built without one is significantly harder than designing the process from the start.
How Dotcode applies it
On medical device software projects, we build design and change documentation into the development workflow itself, so ISO 13485 alignment doesn’t mean stopping engineering to catch up on paperwork.
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