A more defensible way to investigate product reality.
MDARIX is designed for medical-device teams that need connected evidence, visible uncertainty, and accountable human decisions.
An investigation intelligence layer for medical-device teams.
MDARIX is designed for quality, regulatory, product, supplier-quality, and manufacturing teams investigating a product signal across systems of record.
MDARIX connects product context, complaints, changes, suppliers, lots, evidence, uncertainty, and human decisions. QMS, PLM, ERP, and supplier systems remain authoritative.
MDARIX focuses on evidence-bounded investigation: relationships are visible, competing explanations remain separate, missing evidence is explicit, and AI remains advisory.
It does not replace your QMS, PLM or ERP, and it is not a regulatory submission system: it never submits anything to a regulator. Those systems stay the record; MDARIX connects them for investigation.
During a pilot, MDARIX records when each investigation is opened and closed, every data import with its result, every reportability decision with its reason, and every investigation decision with its review and signature, so the pilot can be reviewed from the audit trail.
Try MDARIX free for 30 days.
Your own private workspace, ready-made sample data, and simple templates to try your own records. No credit card, no integration project.
- Request your free trial
Tell us your name, company and work email. With a company email your trial is approved automatically and ready within minutes, up to a daily limit; requests from personal email addresses are reviewed by the MDARIX team, usually within one business day.
- Explore a ready-made investigation
Activate your account from the invitation email. Your private workspace opens with sample data: products, lots, complaints and an investigation to follow.
- Try it on your own data
Download the CSV templates for products, lots, complaints and the components, suppliers, changes and risks around them. Every file is checked for problems and personal data before import, and insights appear straight away.
30 days · up to 3 users · 5,000 uploaded rows. Want live connections to your QMS, PLM or ERP? Ask about becoming a design partner.
Then a pilot on your real data.
When the trial has shown how MDARIX works, the next step is a pilot: MDARIX working on your real complaints, connected to your own systems, run by your own team.
The pilot works on your own records from your complaint, QMS, PLM and ERP systems. There is no sample data in it.
Your pilot has a dedicated MDARIX transactional database, set up only for your organization and run by MDARIX. Your systems stay the systems of record. Free trials share the MDARIX platform, with each organization's records kept apart.
Setup, configuration and validation testing take at least 2 to 3 weeks. The pilot starts once you have signed off the setup.
The pilot runs from 3 months to 1 year, priced for your scope and usage in a written proposal. Design partners receive a discount.