Know what to review before you take action.
Before you place a PO, reorder, onboard a supplier, or check a product file, TrueMedDevice runs a public-record Status Snapshot on your device — FDA or Health Canada — and delivers a source-backed PDF in 2 business days.
One product. One manufacturer. One jurisdiction. $199. Source-backed PDF in 2 business days.
Want to see an example first? Request a sample PDF.
Review support only. Not legal advice, not a regulatory determination, and not a QMS replacement. Your qualified team makes the final decision.
45-second explainer
See how a Status Snapshot helps before a PO.
When a device is about to be ordered, renewed, or reviewed, the public record may already contain signals worth checking. This short video shows how TrueMedDevice turns scattered public records into a source-backed Status Snapshot your team can review before taking action.
Public-data-based research and review support - not a regulatory, legal, import, purchasing, safety, or compliance decision.
Built for the moments your team actually decides.
Not a research project. Not a dashboard to babysit. A way to walk into one of these moments with the public-source evidence already organized.
- Placing a PO
- Importing or reordering a device
- Supplier onboarding
- Customer complaint
- Supplier change
- Software update
- Repair trend
- CAPA question
- PMS review
- Product change
Why this matters
You already have a QMS. We help with the step before the QMS action.
Even with QMS procedures in place, medical-device categories still experience recalls, safety alerts, warning letters, software issues, supplier and process problems, and CAPA findings. Those public incidents are the early-warning surface your team is already supposed to watch — and they can become useful review points before similar risk reaches your own product decision.
The work of converting external public incidents into product-specific review questions is rarely owned by any one part of the QMS. That's the gap TrueMedDevice fills, alongside your existing change-control, supplier-review, software-validation, complaint, and PMS workflows.
What TrueMedDevice does
We organize product-specific supporting information before you take action.
Each output is dated and source-backed. Each one drops cleanly into your existing review and approval steps.
Public signals
FDA and Health Canada recalls, enforcement reports, safety communications, MAUDE, and import alerts surfaced for the device or category in scope.
Comparable incidents
Peer-manufacturer events with the same failure surface — backflow, occlusion, software anomalies, supplier change, alarm drift — pulled into one place.
Regulatory / guidance / standard references
The applicable regulations, guidance documents, and consensus standards your team would otherwise have to track down by hand.
Review questions
Specific questions to ask of design, supplier qualification, software validation, complaint trending, and management review for this product.
Possible action paths
A short list of the choices your team typically faces when this kind of signal lands — framed as options, not directives.
Supplier evidence asks
The validation summaries, change notices, and traceability records worth requesting from suppliers before the next change package or PO.
Supporting record draft
A dated, source-backed draft your qualified team can edit, sign off on, and file in your QMS — review support, not the decision.
What your team gets
Walk into the next review with the evidence already organized.
- Start from a structured review packet instead of a blank page.
- Learn from public incidents before repeating similar failure patterns.
- Ask more specific supplier and internal review questions.
- Keep a dated, source-backed rationale.
- Move into your own QMS workflow with clearer evidence.
- Final decision remains with your qualified team.
Behind the scenes
Every Snapshot files under a Product ID.
Every Status Snapshot creates or reuses a Product ID behind the scenes, so future reviews can stay tied to the same device, manufacturer, jurisdiction, identifiers, and evidence history.
A Product ID is the product-centered file that keeps each review tied to the device, SKU, manufacturer + product, or product family you care about. You don't need to start from a Product ID to order a Snapshot — you start from the Snapshot, and the Product ID is built or matched automatically.
- Product-centered — one Product ID per device, SKU, manufacturer + product, or product family.
- Dated — every review and finding is timestamped.
- Reusable — the next review starts from what's already in the file, not from zero.
- Not a QMS — it's the layer before the QMS action.
- Accumulating — snapshots, risk reviews, assumptions, and supporting records build up under it over time.
Status Snapshot first · deeper review when something happens
Start with the Snapshot. Go deeper when something specific happens.
The Status Snapshot is the public-record check before action. The same Product ID can support a deeper Risk Review when something specific happens later.
Status Snapshot
Use before:
PO, reorder, supplier onboarding, product-file review, tender response, or customer request.
Output:
A dated, source-backed public-record snapshot of what FDA or Health Canada has published about the device.
$199. 2 business days. One product, one manufacturer, one jurisdiction.
Risk Review
When something happens — a complaint, supplier change, software issue, CAPA question, PMS signal, or critical supplier dependency concern — the same Product ID can support a deeper review.
Output:
Review questions, possible action paths, supplier evidence asks, regulatory and standard references, and a supporting record draft.
What this is, and what it isn’t.
This is
- · Public-source research and review support.
- · A persistent, product-specific file for one device.
- · Dated, source-backed outputs that drop into your existing QMS workflow.
This is not
- · Not legal advice.
- · Not a regulatory determination.
- · Not a final marketability or safety verdict.
- · Not a recall predictor.
- · Not a QMS replacement.
Final decisions remain with your qualified RA / QA, regulatory, legal, supplier-quality, and procurement professionals. Our work is the review support that helps that decision happen faster, with cleaner evidence.
Run a Status Snapshot before the PO.
One product. One manufacturer. One jurisdiction. $199. Source-backed PDF in 2 business days. Future Snapshots and Risk Reviews stay tied to the same Product ID.
Review support only. Not legal advice, not a regulatory determination, and not a QMS replacement. Your qualified team makes the final decision.