Join the MedComplyAI Early Access Program
Limited beta seats for medical device teams. Get priority onboarding, direct support, and influence the roadmap.
Our Founder’s Pilot is a paid, limited program for QA/RA teams who want to co-design MedComplyAI and get extended benefits.
We never store or use your documents without explicit consent. See our Privacy Policy.
Founder’s Pilot Now Open — limited seats
We’re inviting a small number of QA/RA teams to co-design MedComplyAI and commit early before we finish building the full tool.
AI-Powered Audit Readiness for FDA & ISO Compliance
Streamline your quality documentation, detect compliance gaps, and be audit-ready— without manual reviews. Currently supports secure, read-only Box folders (no uploads).
Zero-copy analysis · Read-only Box access · AES-256 at rest
MedComplyAI provides AI-assisted audit-readiness insights; it does not replace formal regulatory assessments or confer compliance certification.
1. Automated Audit-Readiness Review
Semantic matching maps documents to relevant clauses—flagging missing or weak coverage with evidence snippets.
2. Audit-Ready Reports
Export clean PDF summaries and traceability CSVs with direct links back to your Box file versions.
3. Secure by Design
Zero-copy analysis: we donʼt store your source documents—only metadata and findings. Read-only Box access with easy revocation.
Connect. Scan. Review. Report.
Step 1 — Connect Box Folder
OAuth sign-in with read-only scope to specific folders (QMS, DHF, Risk, CAPA).
Step 2 — Scan Documentation
AI parses PDFs/DOCX, chunks content, embeds, and maps to FDA/ISO clauses.
Step 3 — Review Findings
See readiness insights and drill into clause-level evidence and remediation tips.
Step 4 — Export Report
Generate audit readiness PDFs and traceability CSVs for internal/external reviews.
Key Features
Designed for small & mid-market medical device teams to reduce audit prep time.
- Document Coverage Insights — clause-level coverage for FDA 21 CFR 820 & ISO 13485.
- AI-Powered Analysis — semantic matching and explainable evidence snippets.
- Box Integration — read-only OAuth connector—no document uploads.
- Audit-Ready Reports — export PDF summaries and traceability CSVs.
Your AI Co-Pilot for FDA 21 CFR 820 & ISO 13485 Audit Readiness
Founded by medical device quality veterans with 20+ years of experience, MedComplyAI helps growing medtech teams stay compliant without the manual document grind. We complement your QMS by analyzing documents where they live—inside your Box environment.
Who benefits
MedComplyAI is built for medical device teams who want predictable audit outcomes.
- Small & Mid-sized Manufacturers — reduce manual review time and avoid common audit findings.
- Regulatory Consultants — deliver faster audits across multiple clients with consistent checks.
- Quality Managers — get clause-level evidence and remediation pointers before an auditor asks.
Accelerate Audit Readiness from Weeks to Hours.
Join the early-access program and help shape the future of AI-assisted compliance.
MedComplyAI Founder’s Pilot Program
We’re inviting a small number of medical device QA/RA teams to join a paid Founder’s Pilot before we complete the full product build. This program is ideal for teams that want to reduce audit-prep time, shape the roadmap, and become early reference customers.
What you get
- Hands-on access to early product prototypes.
- Direct input into feature design and prioritization.
- Founder support during the pilot period.
- Discounted pricing at launch.
- “Founder’s Circle” recognition on our site (optional).
What we’re looking for
- Teams preparing for ISO 13485 or FDA 21 CFR 820 audits.
- Willingness to share feedback in short, structured calls.
- Real document structures (QMS, DHF, Risk, CAPA in Box).
- Commitment to a short, time-boxed pilot.
We’re opening 5 Founder’s Pilot slots. If you’re interested, simply submit the Early Access form and tick “I’m interested in the Founder’s Pilot” — we’ll follow up with details.
Contact Us
Have questions about MedComplyAI or want to schedule a demo? Reach out below or email us directly at support@medcomplyai.com.