Defibrillators · Patient monitors · Suction units
Inspection evidence and release control for medical equipment.
SafeTrace records every test against a versioned procedure, keeps the engineer’s declaration separate from the decision to release, and holds the lifecycle of each device in one record you can show an auditor.
- Versioned procedures with numeric limits
- Separate completion and authorised release
- Quarantine with the reason on record
- EU hosting, MFA and a full audit trail
Who it’s for
For the teams responsible for equipment that has to work.
SafeTrace sits between the desktop software that comes with your analyser and an enterprise maintenance system: built for the people who test, release and answer for medical electrical equipment.
Medical equipment service providers
Independent service companies testing equipment for many clients. Keep each client’s register, sites and reports separate, with one team doing the work.
Ambulance and patient transport
Defibrillators, monitors and suction units across stations and vehicles. Know what is due, what is quarantined and what is ready to go back on a vehicle.
Clinical engineering departments
Small and mid-size teams that need consistent test records and release control without the cost and set-up of an enterprise maintenance system.
Hospitals and clinics
A clear view of device condition, testing and lifecycle across wards and sites, whether the testing is done in house or by a service provider.
How it works
From procedure to certificate, with every decision on record.
Each test follows the same path. The person who tests declares; an authorised person releases or quarantines; the report and the next due date follow.
- 01
Procedure
Engineers work from a published, versioned procedure: each step with its unit and numeric limits, tied to the standard it supports.
- 02
Capture
Results are recorded step by step against the limits, with the test equipment used, its calibration status and photo evidence. Offline capture is coming soon.
- 03
Declare
The engineer declares the test complete. SafeTrace checks the completion gates: required steps, limits, equipment calibration and the acceptance checklist.
- 04
Release
An authorised person releases the equipment for use after two-step sign-in, or it goes to quarantine with the reason recorded. Overrides are recorded with who, when and why.
- 05
Certificate
The inspection report is generated as a PDF with your branding. Next-due dates update, and the record is kept, never overwritten.
Completion is not release.
An engineer completing a test and a quality lead releasing the device are separate steps, by separate permissions. SafeTrace re-checks every gate on the server before it allows either, and asks for two-step sign-in before anyone releases or overrides.
- Pass and fail come from the limits, never typed in.
- Overrides need a reason and are printed on the report.
- Quarantine records the defect and its disposition.
- Released records are versioned, never edited in place.
Product
One record for each device, from commissioning to disposal.
Register, procedures, testing, release, quarantine and reports in one place, instead of spreadsheets, analyser exports and paper sign-off sheets.
Equipment register
Every asset with its modules, serial, UDI, client, site and location (including vehicles), lifecycle history and a QR code. Import from CSV or Excel with a preview.
Procedures and standards
Versioned test procedures with typed steps and numeric limits. Published versions are locked, so every report shows exactly the procedure used.
Release control and quarantine
Completion and authorised release are separate gates. Failed or doubtful equipment goes to quarantine, with nonconformities and their dispositions recorded.
Reports
Inspection reports as PDF, plus equipment inventory, compliance status, inspection history and nonconformity reports as PDF and CSV. Labels with QR codes.
Due dates and alerts
A dashboard of what is overdue, due in 30 and 60 days, in progress and awaiting release, with calibration and consumable alerts and email digests.
API and integrations
A documented REST API with scoped, hashed keys, idempotent writes and signed webhooks, for your maintenance system, ERP or customer portal.
Reports your clients and auditors can read.
Each inspection report carries your logo and wording, every result against its limit, the test equipment and its calibration, the engineer’s declaration and the release decision, with page numbers and a clear watermark until the device is released.
Equipment inventory, compliance status, inspection history and nonconformity reports export as PDF and CSV for each client or site.
Coming soon
These are in development and not yet available. We will say here when each one ships.
Analyser importComing soon
Bring results in from analyser exports, starting with a column-mapped CSV import, and check them against SafeTrace’s own evaluation of the limits.
Offline captureComing soon
Download a work pack and test where there is no signal, in a plant room or an ambulance bay. Results sync when you are back online.
Client portalComing soon
Read-only access for your clients to their own register, released certificates and due lists.
Certificate verificationComing soon
A QR code on each released report opens a public page that confirms the result and release status, with no personal data.
Certificate packsComing soon
One PDF per client, site or visit: a summary sheet followed by every inspection report, with bookmarks.
Later on our roadmapComing soon
- Analyser photo capture: photograph the analyser screen and confirm the values it reads
- Signed, hash-chained certificates anyone can verify
- Daily user checks by QR code, with no login
- Matching of recalls and field safety notices to your assets
- Ready-made procedure packs for common defibrillators, monitors and suction units
Standards
Built around the standards you test to.
Procedures, limits and records shaped by the standards and guidance that apply to medical electrical equipment in Ireland and the UK.
IEC 62353
Recurrent testing and testing after repair
Procedures for in-service electrical safety tests, with measured values recorded against the limits you publish and the test equipment that took them.
IEC 60601-2-4
Defibrillators
Defibrillator checks, such as delivered energy, set up as procedure steps with their limits, alongside pads and battery records.
EU MDR and HPRA
Vigilance and traceability
Quarantine, nonconformity and lifecycle records, with UDI and serial numbers, that support your post-market and vigilance obligations. Reporting to the HPRA stays with you.
HSE and MHRA guidance
Managing medical devices
An equipment register, planned inspection, release decisions and an audit trail that support the record keeping that HSE policy and MHRA guidance on managing medical devices expect.
SafeTrace supports your compliance with these standards and guidance. It is record-keeping software: it is not certified by any standards body, and the procedures, limits and release decisions remain yours.
Security
Evidence you can trust has to be kept properly.
Access is enforced in the database, every change is recorded, and released records cannot be changed after the fact.
EU hosting
Your data is held in the European Union: the database and files in Ireland (Supabase, eu-west-1) and the application in Dublin (Vercel).
Two-step sign-in
Owners, quality managers and engineering leads must use an authenticator app, and so must anyone releasing equipment or overriding a gate.
Append-only audit trail
Every change is recorded by the database itself, with who made it and when. Released records and their reports are versioned, never overwritten.
Per-organisation isolation
Each organisation’s records are separated by row-level security in PostgreSQL, so access is enforced in the database as well as the application.
Least-privilege access
Fixed roles for engineers, quality managers, engineering leads, auditors and client viewers. API keys are scoped, stored only as hashes and revocable.
No patient data
SafeTrace records equipment and the people who test it, not patients. Our data processing agreement and sub-processors are published.
Pricing
Priced by the equipment you manage. Users included.
Start with a 30-day trial. Move up a plan when your register grows.
Starter
For a small team or a single site getting off spreadsheets.
€49per month, ex VAT
- Up to 50 assets
- 3 users included
- Procedures, testing and release control
- Inspection reports and list reports
- Two-step sign-in and full audit trail
For multi-client work
Professional
For service providers and departments testing for several clients.
€199per month, ex VAT
- Up to 500 assets, then €0.30 per extra asset per month
- 10 users included
- Multiple clients, sites and locations
- Your branding on reports
- API access and signed webhooks
- Branded certificate packs
Enterprise
For larger organisations with their own systems and policies.
From €6,000per year, ex VAT
- Unlimited users
- Microsoft 365 sign-in
- Required single sign-on for your organisationComing soon
- Higher API limits and integration support
- Data residency commitments
- Onboarding and data migration
- Prices exclude VAT.
- Every plan starts with a 30-day trial. Users are included in the price.
- Starter and Professional are billed monthly; Enterprise is billed annually.
FAQ
Questions we are asked.
Does SafeTrace replace our analyser’s software?
No. Your analyser still takes the measurements. SafeTrace holds the procedure, the results against its limits, the declaration, the release decision and the report. Import of analyser exports is coming soon; until then results are entered step by step as they are measured.
Is SafeTrace certified to IEC 62353?
No. SafeTrace is record-keeping software and is not certified by any standards body. It supports your compliance by recording tests against the procedures and limits you publish, and by keeping the evidence of who tested, who released and when.
Does it work without a signal?
Not yet. At launch SafeTrace needs a connection while you capture results. Offline capture, as a web app you install on a tablet or phone, is coming soon.
Can our clients see their own records?
A read-only client portal is coming soon. Until then you can send inspection reports by email and export lists for each client.
Do we store patient data in SafeTrace?
No, and you should not. SafeTrace records equipment, tests and the people who do the work. It is not designed for patient information, and our terms ask you not to enter it.
Where is our data held?
In the European Union: the database and files in Ireland and the application in Dublin. Our sub-processors are listed on our legal pages.
Can we bring our existing equipment list?
Yes. Import assets from CSV or Excel with a preview of each row before anything is saved. Enterprise plans include help migrating historical records.
How does the trial work?
Create an account and your first organisation, and you have 30 days to try SafeTrace with your own equipment. Prices exclude VAT, and users are included.
Contact
See SafeTrace with your own equipment.
Send us a recent inspection report and a sample of your equipment list. We will walk you through how they look in SafeTrace, and answer your questions about procedures, migration and pricing.
Or email hello@safetrace.ie. Built in Ireland by Medicore.