The challenge: proving the chain is complete
A Dutch clinic must be able to show an IGJ inspector, for any device, that the whole chain is evidenced: risk assessed, PRI done, staff trained and authorised, maintenance current, technically and clinically released, as the Dutch Leidraad Medische Technologie (2026) requires. Skin & Vision Clinics kept this in three Excel workbooks. But Excel cannot refuse to let you use a device.
The solution: a system that can refuse
Together we built Rexium Quality, a quality and safety management system in which each device's status is derived from the underlying evidence. Incomplete safety requirements trigger automatic blocking; only with complete requirements plus technical and clinical release is a device released; and an expired critical requirement blocks it again.
Next came the VIM incident register under the Wkkgz: a report only closes when the evidence exists, and an improvement action is only complete when a document is attached and its effect has been evaluated. Equipment and incident reports are linked in both directions.
Extension: personnel quality modules
Since September 2026, Rexium Quality also holds the personnel quality modules of the clinic's quality management system, built on the same principle: something is only done when the evidence exists.
The result
Rexium Quality runs in a European environment and was tested against real cases from the clinic. A diathermy unit with an open PRI, open control measures, incomplete training and no clinical release is blocked for exactly those reasons, visible to everyone who wants to use the device. And who may perform which procedure today can be looked up at any moment.