Paige finds every IVD and RUO product in your device marketing, including instruments that only appear in a photo, and checks each page for the statement your rules require.
A brochure page can show an instrument without naming it anywhere in the copy. Paige recognizes the instrument in the photo, works out whether it’s IVD or RUO, and checks for the statement that goes with it.
≈1Recognized from the photo, so the page needs “For In Vitro Diagnostic Use”, even though the copy never names the instrument.
“For In Vitro Diagnostic Use”, from 21 CFR 809.10(a)(4).
“For Research Use Only. Not for use in diagnostic procedures.”, from 21 CFR 809.10(c)(2)(i).
The statement on each page that shows the product, so no page goes out without it.
For example, “Not available in all regions and countries” for products whose status differs by market.
21 CFR 809.10 sets the statements: “For In Vitro Diagnostic Use” for IVD products and “For Research Use Only. Not for use in diagnostic procedures.” for RUO products. Many device companies go further in their own approval rules, such as requiring the statement on every page. Paige checks both.
If an instrument is visible but can’t be matched to a known product, Paige flags the page for your reviewers instead of guessing which statement applies.
≈1An instrument is visible on page 6 but couldn’t be matched to a known product, so Paige can’t confirm which statement applies.
Paige does the first pass on every page, so your reviewers spend their time on the calls only they can make.
Hosted where you need it. Your own Papercurve instance on AWS or OVHcloud, in the region you choose.
See Paige Review on one of your own device brochures, and how it fits the way your team reviews and approves content.
