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. Skin & Vision Clinics kept this in three Excel workbooks. But Excel cannot refuse to let you use a device.
The solution: a register that can block
Together we built Rexium Quality: a digital device register 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.
The system was extended with the VIM incident register under the Wkkgz, protocols, audits, competence and onboarding, all built on the same principle: something is only done when the evidence exists.
The result
The register 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.