Quality Management for medical devices

In medical technology, a quality management system is not optional: Article 10(9) of the MDR requires one from every manufacturer, and in practice that means ISO 13485. The difference from the general ISO 9001 is fundamental — where the latter aims at customer satisfaction and continual improvement, ISO 13485 aims at effectiveness and safety: risk management across the lifecycle, traceability down to the batch, CAPA, supplier evaluation, and post-market feedback.

For buyers, this is therefore not a formality. A supplier without controlled processes forces the manufacturer to monitor that production by other means — incoming inspection, initial sample reports and supplier audits that could otherwise be reduced. Conversely, a certificate does not replace an assessment: what matters is whether its scope covers the service you are buying.

The providers listed here cover two distinct things that are often confused. Some operate a certified system themselves and supply accordingly; others build quality management systems for their clients, run internal audits or provide an external quality management representative. If you are looking for support, check which of the two roles is meant.