Claims support
Benefit statement needs a cited source.
RegAid Regulatory · Available
Every regulatory answer, with its source attached.
Cited answers on a maintained source base, document review, playbooks and change monitoring, for MedTech teams.
Assistant
Ask. Upload. Verify.
- Start with Swiss and EU requirements. Compare other markets when needed.
- Every answer traces back to the source
- Live data for clearances, recalls, registrations, and guidance updates.
- Upload technical files, SOPs, or templates and ask against them.
- Keep the conversation going with your context intact.
Editor
Draft. Review.
- Generate CER sections, PMCF notes, strategy memos, and review comments.
- Versioned drafts with full history
- Inline evidence with click-through to the source
- Reviewer workflows for comments, approvals, and handoff
- Turn cited answers into draft language
- Bring verification and citation into Word
Playbooks
Apply your standards.
- Create rules from source material or templates
- Publish stable review standards for the team
- Run checks against drafts and technical files
- See issues, rationale, citations, and suggested changes
- Share playbooks across the workspace
Published playbook
Technical file review
8acceptable
3review
1change
Needs review
Clinical evidence
CER summary aligns with the cited report.
IFU consistency
Risk language should match approved wording.
Tabular Analysis
Compare. Map gaps.
- Build market comparisons in seconds
- Upload a technical file and see where it falls short
- Map classification, evidence, labeling, and market access requirements
- Every cell traces to its source
- Export to Word, PDF, or CSV when ready for review.
Watchlist
Track regulatory change with cited alerts.
- Pick a topic, jurisdiction, and sources
- Daily or weekly cited digests
- Know when relevant guidance changes
- Shared watchers for team alignment
- Every update links back to the source
Built for regulated markets.
Start with MedTech requirements. Compare markets, trace sources, and keep decisions defensible.
| Jurisdiction | Guidance | Approvals | Labels & IFUs | Assessments | Regulations |
|---|---|---|---|---|---|
| 🇺🇸FDA / FD&C Act-21 CFR | FDA / FD&C Act-21 CFR Guidance: Covered | FDA / FD&C Act-21 CFR Approvals: Covered | FDA / FD&C Act-21 CFR Labels & IFUs: Covered | FDA / FD&C Act-21 CFR Assessments: Covered | FDA / FD&C Act-21 CFR Regulations: Covered |
| 🇪🇺EU MDR/IVDR & EMA | EU MDR/IVDR & EMA Guidance: Covered | EU MDR/IVDR & EMA Approvals: Covered | EU MDR/IVDR & EMA Labels & IFUs: Covered | EU MDR/IVDR & EMA Assessments: Covered | EU MDR/IVDR & EMA Regulations: Covered |
| 🇨🇭Swissmedic / MedDO-IvDO | Swissmedic / MedDO-IvDO Guidance: Covered | Swissmedic / MedDO-IvDO Approvals: Covered | Swissmedic / MedDO-IvDO Labels & IFUs: Covered | Swissmedic / MedDO-IvDO Assessments: Covered | Swissmedic / MedDO-IvDO Regulations: Covered |
| 🇨🇦Health Canada / Medical Devices Regulations | Health Canada / Medical Devices Regulations Guidance: Covered | Health Canada / Medical Devices Regulations Approvals: Covered | Health Canada / Medical Devices Regulations Labels & IFUs: Covered | Health Canada / Medical Devices Regulations Assessments: Covered | Health Canada / Medical Devices Regulations Regulations: Covered |
| 🇬🇧MHRA / UK MDR 2002-UKCA | MHRA / UK MDR 2002-UKCA Guidance: Covered | MHRA / UK MDR 2002-UKCA Approvals: Covered | MHRA / UK MDR 2002-UKCA Labels & IFUs: Covered | MHRA / UK MDR 2002-UKCA Assessments: Covered | MHRA / UK MDR 2002-UKCA Regulations: Covered |
| 🇯🇵🇨🇳🇮🇳+ more | + more Guidance: Covered | + more Approvals: Covered | + more Labels & IFUs: Covered | + more Assessments: Covered | + more Regulations: Covered |
| 🌐ICH | ICH Guidance: Covered | ICH Approvals: Not applicable | ICH Labels & IFUs: Not applicable | ICH Assessments: Not applicable | ICH Regulations: Not applicable |
Frequently Asked Questions
01
What does RegAid cover?
RegAid is focused on MedTech regulatory work, starting with Switzerland and EU MDR/IVDR, with FDA and other markets available for comparison.
02
Should we build our own regulatory RAG instead?
You can build the plumbing. The hard part is the regulatory base itself, curated across jurisdictions, kept current, monitored for change, and cited to the source. That is ongoing regulatory work, not a one-time build. RegAid maintains it as a layer, so your team builds workflows on top instead of maintaining a corpus.
03
Can we connect our own knowledge?
Yes. Connect your own data sources, and RegAid keeps them in sync in a private workspace beside the regulatory base. Your content stays yours and is never used to train models.
04
How is RegAid different from ChatGPT or general AI tools?
RegAid only answers from official regulatory sources. Every answer is cited to the original document. General AI tools have no regulatory source coverage, no citations, no comparison tables, and no change monitoring. If RegAid cannot find a reliable source, it tells you instead of guessing.
05
How accurate are the answers?
Every answer includes clickable citations to the source document. No source, no answer.
06
Does RegAid support CER, PMCF, PSUR, 510(k), and other regulatory workflows?
Yes. Ask workflow questions like "What clinical evidence is required for a Class III CER under MDR?" and get a structured, cited answer. Use comparison tables to map requirements across jurisdictions for any submission type.
07
Can I compare regulations and identify gaps?
Yes. Build comparison tables across Swiss, EU, FDA, and other requirements. Upload your own documents to identify gaps and fill every cell with cited answers.
08
Where is my data stored?
Swiss-hosted (GCP Zurich). GDPR + FADP compliant. Your data is never used to train AI models.
09
How does RegAid Regulatory compare to Veeva Vault RIM or other RIM systems?
RegAid Regulatory is not a RIM platform. Vault, MasterControl, and similar systems manage your regulatory operations. RegAid Regulatory helps you understand what regulators require, draft cited rationale, and run gap analyses before that content enters your system of record. Use it alongside an existing RIM, or on its own if you do not have one yet.
10
Can I install RegAid as an app on desktop or mobile?
Yes. RegAid works like a real app on desktop and mobile. You can install it on Chrome or Edge from the address bar, or add it from Safari using Add to Home Screen (iOS) or Add to Dock (macOS).
Show us the workflow
Bring one question you answered last week.
Twenty minutes on your own case. Leave your email, and the question if you like.