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ISO 13485 recertification passed with zero findings

Sanne de WitSanne de Wit
Company news

The three-yearly audit closed without a single nonconformity.

The three-yearly ISO 13485 recertification audit covered the full chain: parts intake, serialisation, storage, field service procedures and the training records of every engineer. It closed with zero nonconformities — the third consecutive cycle without a finding.

For customers this is more than a plaque. The certificate is what stands behind every declaration of conformity we issue, and what lets hospital quality departments accept our maintenance reports without re-auditing the work. The renewed certificate and updated declarations are available on request from the service desk.