Regulatory-grade product data — accurate, auditable, and built for compliance
In healthcare, product data is not a commercial concern — it is a clinical and regulatory obligation. Inaccurate specifications, missing certifications, or unauthorized changes carry consequences that extend beyond your business.
The status quo
Sound familiar?
These are the friction points we hear from healthcare & medical devices teams, week after week.
Regulatory submissions require data that matches your commercial catalog — exactly
The product attributes your regulatory team submits to FDA or MDR must be identical to what appears in your commercial catalog, with a complete, tamper-evident audit trail. Discrepancies create exposure.
Recall risk from specification errors at the channel level
A wrong device classification, an outdated indication for use, or an incorrect accessory compatibility note in a product listing is not a customer service issue — it is a patient safety issue.
Clinical and commercial teams working from different versions of the same record
Clinical affairs manages device specs through one system. Commercial teams publish from another. The delta between those two records is where your compliance risk lives.
The Brandhubify approach
How Brandhubify works for Healthcare & Medical Devices
Each capability is purpose-built — working together as one connected platform.
Immutable audit trail on every data change
Every field edit is timestamped, attributed to a named user, and version-locked. You can reconstruct the complete history of any product record at any point in time — exactly what FDA 21 CFR Part 11 and MDR require.
Full regulatory audit trail out of the box — no custom development required.
Master Product Hub
Role-based access separating regulatory and commercial data flows
Regulatory teams control the master product record. Commercial teams publish from it — never to it without approval. Unauthorized changes to regulated attributes are structurally prevented.
Eliminates unauthorized data edits as a class of compliance risk.
Master Product Hub
Version-locked product records
Lock a product record to its regulatory-approved version. Future commercial edits create a new version — the approved record remains intact, linked to the submission that references it.
Maintain compliance continuity through every iteration of your product lifecycle.
Asset Library
SKU: BHF-2401 — Version-controlled
23
Current
41
Archived
2
Expiring
—Regulatory Compliance—
Compliance built into the data layer, not bolted on
Regulatory readiness shouldn't require a separate workflow. Brandhubify makes it the default state of your product data.
Submission-ready data export
Export product records in FDA, MDR, or EUDAMED-compatible formats directly from Brandhubify. No manual assembly, no opportunity for transcription errors between internal and submission data.
Explore featureField-level change locking
Lock specific regulated attributes — device classification, indication for use, contraindications — after regulatory sign-off. Changes require a new approval cycle, not just a user edit.
Explore featureRegulatory lifecycle tracking
Track approval dates, resubmission deadlines, and certification expiry across every product in your portfolio. Compliance gaps surface automatically — before they become audit findings.
Explore feature—Quality & Safety—
When data quality is a patient safety matter
Brandhubify gives quality teams the controls they need to ensure that what's published is what's approved.
Two-person rule enforcement
Require a second reviewer for changes to safety-critical attributes. The system enforces the rule structurally — it cannot be bypassed by a single user acting alone.
Change impact analysis
Before a data change publishes, the system surfaces every channel, listing, and document that references the affected attribute — so no downstream impact goes unreviewed.
Device history record support
Maintain a complete, structured history of every product record — aligned with DHR requirements. The full chain of custody of your device data is always accessible.
—Commercial Distribution—
Compliant data, delivered to every commercial channel
Regulatory compliance and commercial speed are not opposites — not when your data infrastructure is designed correctly.
Healthcare-specific channel connectors
Connect to GPO portals, hospital procurement systems, and medical device marketplaces with pre-mapped schemas — including GTIN, GMDN, and UDI data fields.
- Enforced validation rules at every input
- Full visibility across product families
- Scales to 100K+ SKUs without performance loss
UDI-compliant product records
Manage all UDI attributes — DI, PI, issuing agency, and device identifier — within the product record. Ensure every label and listing carries the correct, current identifier.
Multi-market regulatory mapping
Manage country-specific regulatory attributes, CE marking details, and local registration numbers within a single product record — mapped to the correct market at output.
Compliance is not a checkbox. It is infrastructure.
Healthcare teams achieve audit-ready data structures in under 30 days.