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Claims support
Benefit statement needs a cited source.
Swiss-hosted. GDPR + FADP compliant.
RegAid is hosted entirely in Switzerland and complies with both the EU General Data Protection Regulation (GDPR) and the Swiss Federal Act on Data Protection (FADP). All data is processed and stored in Swiss data centers. User data is never used for AI model training. RegAid supports data sovereignty requirements for European life sciences organizations.
Regulatory work, made verifiable.
AI for MedTech teams who need answers, reviews, and drafts they can defend.
RegAid helps MedTech teams ask questions, draft cited responses, compare requirements, and identify gaps across Swissmedic, EU MDR/IVDR, FDA, and other authorities.
RegAid is built for regulatory affairs managers, consultants, quality leads, medical device startups, and MedTech compliance teams.
For CE marking, the technical file must cover Annex II and the post-market elements in Annex III eur-lex.europa.eu. The main gaps are:
- Annex II structure: Device description and intended purpose are present, but the file still needs a clearer Annex II structure eur-lex.europa.eu
- GSPR evidence: The draft includes product description and IFU content, but the GSPR checklist, risk linkage, and verification evidence are incomplete
- Annex III readiness: PMS, PMCF planning, and vigilance procedures still need to be documented for the CE file eur-lex.europa.eu
The technical file is not yet CE-ready. The missing Annex II and III sections should be completed next eur-lex.europa.eu.
Jurisdiction
Global
United States (FDA)
European Union (EMA)
Switzerland (Swissmedic)
United Kingdom (MHRA)
Canada (Health Canada)
China
Nigeria (NAFDAC)
South Africa (SAHPRA)
India (CDSCO)
Japan (PMDA)
Sources
FDA Guidance
FDA Device Approvals
EMA Guidelines
Swissmedic Guidance
CDE Guidance
ICH Guidelines
eCFR
CRLs
MHRA Guidance
Health Canada Guidance
NAFDAC Guidance
SAHPRA Guidance
CDSCO Guidance
PMDA Guidance
Analysis
Analyzing question
Planning retrieval strategy
Searching sources
Reading 12 sources
Drafting grounded answer
Preparing 4 citations
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
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.
Evidence Tables
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.
Monitoring
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
Word Add-in
Validate in Word.
- Select any paragraph and check it against official guidance
- Find and insert citations in one click
- Insert comparison tables directly into your document
- Rewrite regulatory text with tracked changes
- Section-aware review for the document you are working on
Built for regulated markets.
Start with MedTech requirements. Compare markets, trace sources, and keep decisions defensible.
| Jurisdiction | Guidance | Approvals | Labels & IFUs | Assessments | Regulations |
|---|---|---|---|---|---|
| 🇺🇸US (FDA) | US (FDA) Guidance: Covered | US (FDA) Approvals: Covered | US (FDA) Labels & IFUs: Covered | US (FDA) Assessments: Covered | US (FDA) Regulations: Covered |
| 🇪🇺EU (EMA) | EU (EMA) Guidance: Covered | EU (EMA) Approvals: Covered | EU (EMA) Labels & IFUs: Covered | EU (EMA) Assessments: Covered | EU (EMA) Regulations: Covered |
| 🇨🇭Switzerland | Switzerland Guidance: Covered | Switzerland Approvals: Covered | Switzerland Labels & IFUs: Covered | Switzerland Assessments: Covered | Switzerland Regulations: Covered |
| 🇨🇦Canada | Canada Guidance: Covered | Canada Approvals: Covered | Canada Labels & IFUs: Covered | Canada Assessments: Covered | Canada Regulations: Covered |
| 🇬🇧UK (MHRA) | UK (MHRA) Guidance: Covered | UK (MHRA) Approvals: Covered | UK (MHRA) Labels & IFUs: Covered | UK (MHRA) Assessments: Covered | UK (MHRA) 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 |
Pricing
Source-backed AI for MedTech regulatory work.
Monthly
Full access, billed monthly
CHF 199/ seat / month
20 free searches · 30 days · no credit card
- Unlimited searches with cited answers
- Upload and review your own documents
- Gap analysis and cross-jurisdictional comparison
- Regulatory change monitoring with cited alerts
- Team workspaces with role-based access
- Shareable sessions and CSV export
- Swiss, EU, FDA, and global sources covered
Annual
Full access, billed yearly
CHF 1'990/ seat / year
20 free searches · 30 days · no credit card
- Everything in Monthly
- 2 months free (save CHF 398)
- Priority support
Enterprise
For teams that need more
Custom
- Everything in Annual
- Custom source integrations
- Dedicated onboarding
- Priority support
- Volume pricing
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
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 grids, and no change monitoring. If RegAid cannot find a reliable source, it tells you instead of guessing.
03
How accurate are the answers?
Every answer includes clickable citations to the source document. No source, no answer.
04
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 grids to map requirements across jurisdictions for any submission type.
05
Can I upload my own documents and compare them against regulations?
Yes. Upload technical documentation, IFUs, risk summaries, CER or PMCF drafts, protocols, or submissions. RegAid shows the gaps with citations to the source.
06
Can I compare regulations and identify gaps?
Yes. Build comparison grids across Swiss, EU, FDA, and other requirements. Upload your own documents to identify gaps and fill every cell with cited answers.
07
Where is my data stored?
Swiss-hosted (GCP Zurich). GDPR + FADP compliant. Your data is never used to train AI models.
08
How much does RegAid cost?
CHF 1,990/seat/year (or CHF 199/seat/month). Free trial, no credit card required.
09
Can I try it first?
Yes. Sign up and start drafting immediately, no credit card required.
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).