ISO 13485 sets out the requirements for a quality management system specific to the medical device industry — from design and development through to production, installation and servicing. It's closely aligned with regulatory frameworks such as the UK MDR, and is typically expected of any organisation in the medical device supply chain, not just manufacturers.
Ask About ISO 13485Formal controls over how devices are designed, verified and validated.
Managing product risk in line with ISO 14971 throughout the device lifecycle.
Full traceability of components and processes, aligned to regulatory submission requirements.
Structured monitoring and reporting once a device is on the market.
We assess your current position against ISO 13485 and scope exactly what's needed.
We build the management system documentation around how your business actually operates.
We train your team so the system is understood and owned, not just filed away.
We support you through the external audit, and beyond into ongoing maintenance.
