REGARA™ compresses the years of regulatory work behind every medical device, drug, and diagnostic — drafting submissions, surfacing precedent, and keeping every claim defensible.
The subject device is substantially equivalent to the predicate K203482 (Predicate A) with respect to intended use, technological characteristics, and performance. Minor differences in the optical assembly do not raise new questions of safety or effectiveness.
Bench performance testing per ISO 80601-2-61:2017 demonstrates equivalent oxygen saturation accuracy (ARMS ≤ 3.0%) under both motion and low-perfusion conditions, consistent with the predicate's labeled claims.
Three guidance documents apply to this device class. The most recent (Sept 2024) shifts cybersecurity expectations — see the suggested edit to §9.
From predicate search to RTQ drafting — every output cites its evidence.
Most regulatory time is spent finding the relevant guidance, predicate, or precedent — not authoring the argument that follows from it.
FDA issued 312 new and revised guidance documents in 2024 alone. A submission written six months ago may already be obsolete in three sections.
If a reviewer can't trace a sentence back to its evidence in under a minute, the deficiency letter is already drafting itself.
Chat tools hallucinate citations and miss the difference between a Special 510(k) and a Traditional one. Regulators notice.
REGARA™ writes against the agency, device class, and submission type you select — pulling from the current FDA, EMA, PMDA, and NMPA guidance corpora.
Each generated sentence is anchored to the predicate, standard, or study that supports it. Click any claim to see the evidence.
Integrates with Veeva, MasterControl, Greenlight Guru, and SharePoint. Exports to eCTD, eSTAR, and IDMP without re-formatting.
"We built REGARA™ because we spent careers asking why a submission has to take a year. The answer was never because the science is hard."
From Class I through PMA, with predicate intelligence and substantial equivalence drafting that holds up under review.
Explore Pharma & BiotechModule 2 summaries, response-to-questions drafting, and label negotiation support across FDA, EMA, and PMDA.
Explore In Vitro DiagnosticsIVDR technical documentation, performance evaluation reports, and the FDA's evolving LDT framework — handled.
Explore Digital Health & SaMDPredetermined Change Control Plans, GMLP, and the cybersecurity expectations of the 2023 guidance — out of the box.
ExploreWe curate, version, and re-index every guidance document, standard, and consensus publication that touches medical product regulation. Daily.
REGARA™ drafts faster than a regulatory team writing from scratch — and to a higher standard, because every section is anchored to current guidance, precedent, and the customer's own evidence base.
Every prompt, edit, and citation is captured. Reproduce any submission, on any date, in one click.
A 30-minute walkthrough on a submission of your choosing. We bring the demo data — or you bring yours, under NDA.