For lubricant, condom and therapeutic-device brands

The clock starts the day anyone at the company heard.

Vigil logs every complaint about a medical device — product, lot, the day the company first heard, what happened and the harm — says as you type whether it meets the reporting triggers, records the decision with its reason, and counts each Medical Device Report clock: 30 calendar days, or 5 work days with weekends and holidays skipped.

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Opens in this browser with an invented device brand already in it. No account, no email address, nothing installed.

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The problem

Condoms and many lubricants are medical devices.

Their makers must report to FDA within 30 calendar days of learning that a device may have caused or contributed to a death or serious injury, or malfunctioned in a way that could. Some events need a report in 5 work days. “Becoming aware” is the day anyone at the company heard — a customer-service ticket counts.

30 days

to report after learning a device may have caused or contributed to serious injury, or malfunctioned.

21 CFR 803.50 →

5 work days

when remedial action is needed to prevent substantial harm, or FDA asks in writing.

Anyone

at the company hearing of it starts the clock.

Will not let a report slip quietly past its day.

Late and nearly-due reports lead the file. A complaint marked not reportable whose record says serious injury is flagged, and so is a decision with no reason or a complaint undecided after 14 days. Three complaints about one product in 90 days is called out as a pattern. Filed needs the date and the eMDR confirmation.

How it works

Complaints, clocks, the file

Log each complaint

Product, lot, ticket, the day first heard, what happened, the harm, malfunction, remedial action, and the decision with its reason.

Watch the clocks

Every reportable complaint with its 30-day or 5-work-day clock, due date and days left. Mark it filed with the eMDR number.

Print the file

Late reports first, flagged decisions, patterns, and each complaint’s discard date.

What it will never do

It counts the clock. The company decides.

Vigil files nothing with FDA. Whether an event is reportable is the company’s decision; Vigil records it.

No FDA link.You file on eMDR; Vigil keeps the confirmation.

No customer data.A ticket reference, not a customer.

It is not a lawyer.Not legal advice.

It never touches a payment.The subscription is for software.

Pricing

Priced per company

Less than an hour of a regulatory consultant.

Most brands

One company

$15/month

One device brand, every product.

Every complaint and decision
30-day and 5-work-day clocks
Patterns called out

One company, yearly

$150/year

The same, two months free.

Everything in One company
Discard dates kept
Export for your consultant

Subscription. Your bank statement says Vigil Software. Refunded in full on request within 30 days. Your licence key is emailed to you within two working days of payment.

Checkout is our own bitcoin server, not a card processor — nobody we had to apply to and nobody who can close the account. The button takes you straight to it. Give your email address there — that is where your key is sent.

Questions

The ones we actually get asked

Is a lubricant really a medical device?

Many personal lubricants are, and condoms are. Check your product’s FDA classification.

When does the clock start?

The day anyone at the company became aware of information that reasonably suggests a reportable event.

How long are files kept?

Two years from the event or the device’s expected life, whichever is longer. Vigil shows the date.

Is this legal advice?

No. It is the clock you wish you had kept.

What do I actually get when I pay?

The demo on this page is the whole program, running on invented records. Paying gets you a licence key — one line of text, emailed to the address you give at checkout within two working days. Paste it into the program and from then on it keeps your own records. Until then, nothing you type into it is kept.

The key is checked inside the page, on your own machine. It never calls us, so there is still no account and nothing about your business goes anywhere. If you ever stop paying, your records stay exactly where they are, read-only, and Export still hands you every one of them.

Open the demo before the next ticket

The invented brand has a massager burn five days past its report, a broken condom with three days left, a recall on the five-work-day clock, an emergency-room complaint wrongly marked not reportable, three complaints about one lubricant in 90 days, and one undecided for 18 days.

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