ISO 13485 - Quality Management System for Medical Devices
What is ISO 13485?
ISO 13485 is the Quality Management System standard for medical devices. It follows the logic of ISO 9001 but with stricter requirements for documentation, traceability and risk management, oriented towards regulatory compliance rather than customer satisfaction alone.
Who is ISO 13485 for?
It applies to manufacturers of medical devices, importers and distributors, sterilisation and testing laboratories, companies providing technical support for medical equipment, and software companies whose product qualifies as a medical device.
Benefits of ISO 13485
- A basis for CE marking under Regulation (EU) 2017/745
- Full traceability of batches and products
- Structured risk management in line with ISO 14971
- Controlled design and change processes
- Access to international markets
- Smoother audits by notified bodies
- Documented handling of complaints, incidents and recalls
- Eligibility to participate in hospital tenders
Certification Requirements
The ISO 13485 management system must meet the applicable legal requirements concerning the business, as relevant either Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostics, as well as the requirements of the standard. A technical file per product and a post market surveillance procedure are required.