When something happens, know what to review next.
TrueMedDevice helps medical device teams connect external signals and internal events to the right device, the right regulatory context, and a review-ready decision flow.
So your team can make faster, better-supported judgments — and keep a clear record of why.
From event to review-ready context
A complaint comes in. What should be reviewed first?
Instead of starting from scratch, see the device involved, the relevant regulatory context, and the issues that may need attention — in one place.
The problem you know too well
A competitor recall lands. A customer complaint comes in. An FDA enforcement action drops. Your team needs to answer: does this affect our product? What should we do? And can we prove we reviewed it?
Hours of manual cross-referencing
Open FDA databases, check ISO standards, cross-reference guidance documents, write up a rationale in Word. For every signal. For every product.
Signals fall through the cracks
No system connects external recalls and enforcement actions to your specific product’s regulatory obligations. Things get missed.
Auditors ask, you scramble
“Show me your review of that recall.” If the answer isn’t documented with rationale and traceability, you have a finding.
Start from your product, not from a database
TrueMedDevice maps the regulatory landscape for your specific device, then uses that map to assess every signal that matters.
Register your product
Enter your device details. The system maps applicable FDA regulations, ISO standards, and guidance documents automatically.
Your regulatory map
See every regulation, standard, and requirement that applies to your product — organized, traceable, and always current.
Signals assessed
Recalls, complaints, enforcement actions — external or internal. Each one matched to your product’s map with impact level and rationale.
Evidence card exported
Review the assessment, confirm or adjust, and generate a documented evidence card with full traceability for your QMS.
“Not just peace of mind — confidence that your review is grounded, structured, and explainable.”
Built for RA/QA teams, R&D engineers, and consultants who are responsible for what happens next.
Why this matters
Regulatory review is not optional. The difference is whether you do it reactively under pressure, or proactively with a system that documents everything.
Reduce regulatory risk
No signal goes unreviewed. Every decision is documented with rationale and traceability. When an auditor asks, the answer is already in your QMS.
Save hours per review
Stop manually cross-referencing FDA databases, ISO standards, and guidance documents. The regulatory map is built once and maintained automatically.
Handle complaints with confidence
Paste a customer complaint or repair ticket. The system identifies your product, assesses regulatory impact, and generates a documented review in minutes.
Scale across products
Each product gets its own regulatory map, signal queue, and evidence trail. Add devices without adding headcount.
Start with one product
$9930-day trial
Full regulatory map, signal matching, review workflow, and evidence card export for one product. See what your auditor will see.
30-day refund guarantee. $99 credited toward subscription.
Multi-product plans from $199/mo · Contact us
Common questions
What problem does TrueMedDevice solve?+
When your device gets a customer complaint, a competitor recall, or an FDA enforcement action, your team needs to assess the regulatory impact, document the rationale, and file evidence in your QMS. Today this takes hours of manual cross-referencing. TrueMedDevice does it in minutes by starting from your product and mapping all applicable regulations, standards, and signals automatically.
How is this different from monitoring tools?+
Most tools track FDA databases and send alerts. TrueMedDevice starts from your specific product, maps which regulations and standards actually apply, then when a signal arrives, the system assesses its impact with documented rationale. You review, confirm or adjust, and export an evidence card. The output is a defensible, traceable review record.
What is an evidence card?+
An evidence card is a structured document containing the signal, which product it affects, which regulations and standards are relevant, the system assessment, your team’s decision and rationale, and suggested next actions. It goes directly into your QMS and answers the auditor’s question: what did you review and why did you decide this?
What about internal signals like customer complaints?+
Paste a complaint, repair ticket, or field issue into the system. It identifies which of your registered products is affected, pulls the product’s regulatory map, assesses the impact, and generates the same structured evidence card. Every internal signal gets a documented review process.
How is this different from an eQMS?+
Your eQMS manages internal processes — CAPAs, document control, training. It does not monitor external regulatory signals or map regulations to your product. TrueMedDevice handles the regulatory intelligence side: what applies to your device, what happened, and what is your documented response. The evidence cards export into your eQMS.
Can I use this for multiple products?+
Yes. Each product gets its own regulatory map, signal queue, review history, and evidence trail. Add your infusion pump, your monitor, and your diagnostic — each one is independently tracked. Consultants use this to manage multiple client devices from one workspace.
Stop cross-referencing. Start documenting.
Register your product and see the regulatory map, matched signals, and what an evidence card looks like — in minutes.
Set Up Your Product