RAi (pronounced "ray") plugs into your QMS, Egnyte, and Outlook to answer regulatory questions, review submissions, and flag compliance gaps — with citations to 21 CFR, FDA guidance, and your own SOPs. A Clemtech Medical Solutions product.
Pick a scenario on the left. RAi answers like a senior regulatory consultant — citing the exact regulation, guidance document, or your internal SOP.
One copilot that replaces ad-hoc consultants, late-night CFR searches, and "did anyone ever document this?" emails.
Every answer is grounded in 21 CFR, FDA guidance, ICH, ISO 13485/14971, and your own SOPs — with links you can click.
Upload a 510(k), Design History File, or IND module. RAi flags missing sections, weak rationales, and predicate inconsistencies.
Every question, answer, and source is logged. Export to PDF for inclusion in your DHF or audit response.
Connects to Greenlight Guru, MasterControl, Veeva, and SharePoint. Asks "what does *your* SOP say?" before answering.
Pulls FDA correspondence, AI/ML hold letters, and reviewer questions from Outlook and drafts compliant responses.
SOC 2 Type II. HIPAA-ready. No training on your data. Optional Part 11 e-signature workflow for QMS integrations.
No data migration. RAi reads from your existing systems in seconds.
Cancel anytime. Annual plans get two months free. Enterprise includes implementation services.
The AI regulatory consultant. For RA/QA teams who need cited answers, fast.
Everything in FDA Guide, plus a full FDA-aligned QMS with templates and design controls.
For consultancies, large pharma, and multi-product portfolios.
All plans include cited answers, audit logs, and SOC 2 Type II security. Usage credits cover AI consultation, document analysis, and template generation. Overage rate $0.50 per credit. 14-day free trial on FDA Guide and QMS Suite. No setup fees.
Get a personalized walkthrough with one of our regulatory specialists. We'll show you RAi on your own SOPs and submissions, under NDA.
20 minutes. We'll show RAi working on a submission like yours.