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Vigilance

Device complaints investigated, reportability decided under the regime you name, and field safety actions worked serial by serial.

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What it is

For a device maker, importer or distributor, and for a hospital logging a fault with a device it uses. A complaint names the unit on InstalledBase, or a device and serial typed in, what happened as reported, and whether a person was involved and what happened to them as reported. The investigation is in the investigator’s words. Whether it is reportable is decided per regime you name — the India Medical Devices Rules 2017, the Materiovigilance Programme of India, US FDA Medical Device Reporting, the UK MHRA, Australia’s TGA, or another — by a person, with their reasons and where the criteria they applied come from, and a report date only with its source; MedAppz ships no criterion, threshold or deadline. A decision is kept as decided; the filing is added once, with its reference. A complaint closes only once investigated, decided, and filed wherever it was reportable. A field safety corrective action lists the affected serials — the model’s units on InstalledBase matching a serial pattern, and the hearing aids AudioLab fitted that match — and closes only when each has an action: notified, corrected, replaced, returned, or not reachable with what was tried.

Who uses it
Built for: Every specialty
Reads
InstalledBase units, AudioLab fitted hearing aids
Writes
Complaints, investigations, reportability decisions and filings, field safety actions
Never
It does not decide whether a complaint is reportable or file anything with a regulator: a person decides and files, and records it here.
Access
Only people whose role includes it — the clinic owner decides who
Your data
PHI-lite. Hosted in Boston, United States. On uninstall: The list stops; every complaint, decision and field action is kept.

In the product

Who uses it
Quality officer — the demo profile it is best tried as
Where it opens
Compliance › Vigilance /vigilance
Permission
vigilance.read
Every compliance app in the handbook →

How it works

  1. Log the complaintThe unit, what happened, who was involved.
  2. Investigate and decideYour words, per regime, with your criteria’s source.
  3. Record the filingOnce, with its reference; then close.
  4. Work a field actionEvery affected serial, until each is done.

Rules it keeps

What it does not do, by design. A listing with only benefits is an advertisement.

It does not decide whether a complaint is reportable or file anything with a regulator: a person decides and files, and records it here.
It ships no criterion or deadline.

AI in Vigilance

AskQuestions about what is on screen — “What needs attention in Vigilance today?” — answered with the records it read.
DraftSummaries and notes for the team, marked as drafts until a person signs.
Every answer shows its sources. Nothing AI writes is saved until a person accepts it.

See it on screen

Live product
01Vigilance — Investigate device complaints, decide reportability, and work field safety actionsCaptured from the running demo clinic
Vigilance — Vigilance — Investigate device complaints, decide reportability, and work field safety actions
1 of 1

Connected to

Read out of the code, not the brochure: each app below is here because one service queries the other’s tables. Install either side and the hand-over is already wired.

See the whole clinic →

Questions clinics ask

What does Vigilance do?
Device complaints investigated, reportability decided under the regime you name, and field safety actions worked serial by serial. For a device maker, importer or distributor, and for a hospital logging a fault with a device it uses. A complaint names the unit on InstalledBase, or a device and serial typed in, what happened as reported, and whether a person was involved and what happened to them as reported. The investigation is in the investigator’s words. Whether it is reportable is decided per regime you name — the India Medical Devices Rules 2017, the Materiovigilance Programme of India, US FDA Medical Device Reporting, the UK MHRA, Australia’s TGA, or another — by a person, with their reasons and where the criteria they applied come from, and a report date only with its source; MedAppz ships no criterion, threshold or deadline. A decision is kept as decided; the filing is added once, with its reference. A complaint closes only once investigated, decided, and filed wherever it was reportable. A field safety corrective action lists the affected serials — the model’s units on InstalledBase matching a serial pattern, and the hearing aids AudioLab fitted that match — and closes only when each has an action: notified, corrected, replaced, returned, or not reachable with what was tried.
What data does Vigilance read and write?
Vigilance reads InstalledBase units, AudioLab fitted hearing aids and writes complaints, investigations, reportability decisions and filings, field safety actions. Its data class is PHI-lite. Every app works on the same patient record — nothing is copied into a silo.
What does Vigilance deliberately not do?
It does not decide whether a complaint is reportable or file anything with a regulator: a person decides and files, and records it here. It ships no criterion or deadline.
What happens to our data if we uninstall Vigilance?
The list stops; every complaint, decision and field action is kept.
Is Vigilance available today?
Yes — Vigilance is live in clinics today. Set up your practice on MedAppz and install it from your dashboard.

Want to see Vigilance running on your own patients?

Tell us what you run and we will show you this app inside a practice shaped like yours — or answer the question the page above did not.

We use your name, phone number and clinic name for one thing: to answer this enquiry about MedAppz. It is stored on our own server, in the single region our trust centre names, and it is not sold or passed to anyone else.

Email us

You can withdraw either at any time: write to hello@medappz.com, or tell whoever calls you, and we will delete what you gave us.

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