Excel cannot refuse to let you use a device. Rexium Quality can.
Rexium Quality is the quality and safety management system for clinics. It started as a digital device register (hulpmiddelenoverzicht) with safety-release control, built to the Dutch Leidraad Medische Technologie (2026), and now also carries the incident register and the personnel quality modules of your quality management system.
Dutch clinics must be able to show an inspector from the Health and Youth Care Inspectorate (IGJ), 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. Rexium Quality now guards that chain, and steps in when it is incomplete.
Automatic blocking
Incident register
Staff & competence
Inspection ready
Status derived from evidence, not typed in
Rexium Quality stores no status that can drift. Every time you look, it recalculates whether something is safe and complete, based on the underlying evidence. The same principle applies to devices, incident reports, competence and onboarding.
- Incomplete safety requirementsAutomatic blocking
- Complete + technical + clinical approvalReleased
- Expired critical requirementAutomatic re-blocking
A report only closes when the evidence exists
Rexium Quality carries the VIM register (Veilig Incident Melden), required of every Dutch care provider by the Wkkgz. The same interlock applies: a report cannot be closed until the evidence for closing it exists.
An improvement action is not complete because someone wrote 'done'. It is complete when a document is attached to it and its effect has been evaluated afterwards.
- Intake, triage and analysis using the Eindhoven model
- Improvement actions with evidence and effect evaluation
- Calamity assessment with tracking of the IGJ reporting deadline
- Email notifications, reminders and escalation
Equipment and incidents are linked in both directions
A VIM report about equipment can raise a malfunction on the device, which blocks it if patient safety is affected.
In the other direction, a malfunction that reached patient care unnoticed offers the reporting form directly. No signal gets lost between two registers.
Who may do what, and can you prove it?
Since September 2026, Rexium Quality also holds the personnel quality modules, built from the clinic's quality management protocol manual and its approach to digital staff assessment and development.
Evidence counts here too: an onboarding programme cannot be closed while a required procedure has no release, and the overview of who may do what today is calculated rather than maintained by hand.
- Procedures & competence: a digital competence assessment, three signatures and release by the medical director
- An onboarding programme per role, closed with three signatures
- 360-degree feedback for doctors, with patients responding anonymously via a single-use code
- Performance reviews with preparation, the employee's response and development actions
Everything for demonstrable quality and safety
Medical devices
Device register
A register of all medical equipment, with a status always derived from current evidence.
Risk classification and PRI
Classification B and the PRI assessment form for clinics, with control measures per risk.
Technical and clinical release
A release gate that shows per requirement what is missing, and refuses incomplete release server-side.
Training and authorisation per device
Training and authorisation per employee and per device, with dual sign-off.
Maintenance, malfunctions and recalls
Maintenance history, malfunction reports and safety recalls that feed straight into device status.
QR at the point of use
Scan a device and see instantly whether it is released, even on a phone at the treatment chair.
Staff
Procedures & competence
Who may perform which reserved or high-risk procedure independently: a digital assessment, three signatures and release by the medical director. The overview is calculated, printable and exportable.
Onboarding programme
A programme per role, closed with three signatures and refused while a required procedure has no release.
360-degree feedback
For doctors: patients answer with a single-use code, and who was asked is kept apart from what they said.
Performance reviews
Private preparation, a report the employee responds to, 'seen' kept apart from 'agreed', and development actions.
Quality & accountability
Incident register (VIM)
Reports, analysis, improvement actions with evidence and a closure gate, linked to the equipment.
Protocol management
Numbering per document type, an implementation plan that decides who must read a version and by when, and text that locks on submission.
Audits and responsibility matrix
Internal audits and an overview of tasks, responsibilities and authorities (TVB matrix).
Auditor role
A read-only role for auditors and inspectors that always has an end date.
My tasks
One list of everything a person still owes, across all modules.
Audit trail, roles and EU hosting
An append-only audit log, an interface that only offers what your role may do, and data in the EU.