Excel cannot refuse to let you use a device. Rexium Quality can.
Rexium Quality is the digital medical device register (hulpmiddelenoverzicht) and release control for medical technology, built to the Dutch Medical Technology Guideline (Leidraad Medische Technologie, 2026).
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
Dual release
Incident register
Inspection ready
Status derived from evidence, not typed in
Rexium Quality stores no status that can drift. Every time you look, it recalculates whether a device may be used, based on the underlying evidence.
- Incomplete safety requirementsAutomatic blocking
- Complete + technical + clinical approvalReleased
- Expired critical requirementAutomatic re-blocking
A report only closes when the evidence exists
Rexium Quality also 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.
Everything the Guideline asks of your clinic
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
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.
Concessions and decommissioning
Controlled concession use with a deadline, and recorded decommissioning.
Protocols
Version control with review and approval; clinical protocols are approved by the medical director.
Competence
Competence for reserved and high-risk procedures, plus onboarding programmes for new colleagues.
Audits and responsibility matrix
Internal audits and an overview of tasks, responsibilities and authorities (TVB matrix).
QR at the point of use
Scan a device and see instantly whether it is released, even on a phone at the treatment chair.
Audit trail and roles
An append-only audit log and an interface that only offers what your role is allowed to do.
European hosting
Application and data run in the EU, in the same region for speed and compliance.