Medical devices (ISO 13485)

In addition to medicinal products, Sanicura Medical distributes medical devices. For this area we operate a quality management system to ISO 13485 — the international standard for medical devices.

Our scope

• Compliant storage of medical devices under controlled conditions
• Traceability by batch and serial number
• Adherence to manufacturers' transport and storage requirements
• Interface between manufacturers and users in the medical environment

Why ISO 13485 matters

For manufacturers and buyers, a distributor's certified QM system is a key selection criterion. It demonstrates documented, monitored and regularly audited processes.