Spatial CMMS for Medical Device Manufacturing
MYREX is a Spatial CMMS for medical device manufacturing, built around a high-definition 3D capture of each machine. Work is recorded with an attestation by an identified user and written to an audit log secured by a SHA-256 hash chain, and the evidence attached to it — photos, video, notes — is pinned to the exact location on the equipment it was taken at.
What does a device plant need from maintenance software?
Equipment that runs a controlled process has to be maintained on a defined basis, and the maintenance has to be traceable: which machine, what was done, by whom, when, and on what evidence. Under 21 CFR 820.70(g), the quality system regulation for medical devices, equipment used in production must be maintained on a schedule that ensures it continues to meet specified requirements — with maintenance activities, including their dates, documented. This is not a facilities matter; it is an explicit part of the device master and quality record. 21 CFR 820.75 adds a related requirement for process validation: where the results of a process cannot be fully verified by subsequent inspection, the process must be validated with a high degree of assurance, and the equipment used has to be qualified as part of that. The maintenance record that keeps a qualified piece of equipment in its qualified state is a downstream input to 820.75, not the validation itself. MYREX holds the maintenance record: identity through Microsoft Entra, so the name attached to the work is the organization’s own directory identity; attestation on completed work; and a SHA-256 hash chain across the audit log, where each entry incorporates a hash of the one before it — so alteration is detectable rather than prevented. That, precisely, is what “tamper-evident” means here.
A word about “validation”, and where FDA’s Computer Software Assurance guidance fits
Worth separating before anything else, because the same word covers different exercises, and the distinction decides what a vendor can honestly claim. FDA’s Computer Software Assurance (CSA) guidance — final, September 2025 — is scoped to medical device production and quality systems under 21 CFR Part 820, which is exactly this page’s domain. CSA reframes software assurance for production and quality-system software as a risk-based activity: assurance effort should be proportional to the risk the software poses, with an emphasis on critical thinking over exhaustive documentation for low-risk uses. It is citable here — unlike on a pharmaceutical drug-manufacturing page, where it does not apply, because that context sits under 21 CFR Parts 210/211, not Part 820. Applied to MYREX: a risk-based CSA approach would scope assurance effort to the functions that carry regulatory weight — record integrity, the audit trail, attestation, and the functions that feed a maintenance record depended on for 820.70(g) — rather than treating every feature as equally critical. That scoping determination is yours to make, informed by your own intended use, not a category we assign ourselves.
Process validation (820.75)
Demonstrating that a manufacturing process consistently produces a conforming result. MYREX does not perform it — it records the maintenance the process equipment receives.
Equipment qualification (IQ/OQ/PQ)
Demonstrating that a piece of process equipment is installed as specified, operates across its range, and performs in routine use. MYREX does not perform it — it holds the ongoing maintenance record that qualified equipment depends on.
Computer software assurance / validation
Establishing that a computerised system used in production or the quality system is fit for its intended use, scoped by risk under CSA. You perform it, for your intended use. We support it and do not claim to have done it for you.
No vendor can sell you a validated system. What a vendor can honestly offer is a product designed in alignment with 21 CFR Part 11, and real detail to support the work you have to do yourself.
What does MYREX actually record?
Stated plainly, so a quality lead can map it onto their own framework rather than take a claim on trust.
Who
The signed-in user, through Microsoft Entra directory identity
What
The work order or procedure, and the steps completed in guided mode
Which asset
The specific machine, with its own asset page and full activity history
Where on the asset
Marks (pinned locations on the machine) carrying the photos, video and notes taken there
When
Timestamps on each recorded action in the audit log
Completion
An attestation by the identified user on completed work
Integrity
Maintenance records and attestations written to an audit log secured by a SHA-256 hash chain; administrative changes to accounts and roles are recorded but sit outside the chain
Why does the location matter in a controlled process?
Because “this machine was maintained” and “this point on this machine was maintained” are different statements, and only the second survives a question about a specific feature of the equipment. A conventional record answers which asset, what task, who, when. In MYREX, the evidence attached to that record also answers where on the asset — so the history of a fixture, a seal or a sensor is readable as the history of that spot. What do technicians do on the floor? They open the machine, find the place, and run the procedure step by step in guided mode. Completed steps write to the record and completion carries an attestation. Where something is found outside a procedure, the technician taps the spot on the 3D scene and reports it there — one action that creates a work order and a mark at the click position. It runs in the browser on the tablets crews already carry.
What actually ships today?
High-definition 3D capture of each machine
Shipped
Photos, video and notes pinned to exact locations on the machine
Shipped
Abnormality tags raised on the 3D scene, carrying the exact location
Shipped
Step-by-step guided mode
Shipped
Work orders — create, assign, complete
Shipped
Preventive maintenance (PM) calendar with recurring events linked to locations on the machine
Shipped
Asset pages with full activity history
Shipped
Report-a-problem escalation
Shipped
Media library
Shipped
Search across assets, marks (pinned locations on the machine), media, procedures, procedure steps and activity
Shipped
Manager dashboard — open, overdue, due-today and unassigned counts, with due dates
Shipped
Audit log, secured by a SHA-256 hash chain
Shipped
Attestation on completed work
Shipped
Microsoft Entra sign-in
Shipped
Per-step location anchoring of procedures
In development
Spanish (LatAm)
In development
Search is plain keyword matching across six result types today — not full-text, fuzzy, semantic or instant. Ask us rather than assuming about anything not in this table — retention and archival configuration, records export for an inspection, documentation to support your software assurance, approval workflows beyond attestation, and hosting.
Frequently asked
Is MYREX validated?
No vendor can sell you a validated system. Computer software assurance and validation are performed by you, for your intended use, in your environment. MYREX is designed in alignment with 21 CFR Part 11, and we will support your validation with the detail you need rather than claim to have done it for you.
Does MYREX meet ISO 13485 or 21 CFR 820 requirements for equipment maintenance records?
Requirements are met by your quality system, not by a product. What MYREX provides is the record: attributable identity through Microsoft Entra, attestation on completed work, per-asset activity history, a preventive maintenance (PM) calendar, and a tamper-evident audit log. How that maps to your procedures under 820.70(g) is a determination you make.
Does MYREX have electronic signatures?
MYREX records an attestation by an identified user on completed work. Whether that satisfies a signing requirement under a given rule is a determination you make in your validation, and we will support it with the detail you need.
What does “tamper-evident” mean?
Each audit-log entry incorporates a cryptographic hash of the previous entry, so altering or removing an entry breaks the chain from that point forward. Changes are detectable, not prevented.
Does MYREX handle equipment qualification?
No. Qualification is an exercise performed on the process equipment under 820.75. MYREX records the maintenance that qualified equipment receives afterwards, including where on the machine it was done.
Can we start with one cell or one line?
Yes. Capture those machines, run the PM and corrective work there, and extend from a working example.
See it on your own line.
Bring a machine you already know is a mess to explain, and we will show you what it looks like inside MYREX.