Cygnus Health was founded by medical device manufacturing industry veterans with over 20 years of hands-on experience. We know first-hand the stress and heavy operational burden of getting ready for Notified Body audits, updating technical files, and keeping QMS documentation compliant.
Our platform is built to solve this exact bottleneck. By automating the mapping of audit requirements, tracking compliance deadlines, and assisting document generation, we help your organization remain permanently audit-ready.
Our goal is simple: let Cygnus Health handle the heavy compliance lift, so your R&D teams can stay completely focused on designing next-generation medical technologies.
Privacy Policy & Terms
1. GDPR Compliance & Data Controller
Cygnus Health acts as the Data Controller for your registration credentials and platform settings under GDPR. Your data is stored securely and processed lawfully to enable our automated audit services.
2. Storage & Encryption
All checklist status metrics and evidence document links are encrypted in transit and at rest. No medical device specifications or raw documentation are sold or shared with third parties.
3. AI Mode Data Processing
If you choose to enable AI Assistant Mode (Cloudflare Worker AI), the questions you type are transmitted to Cloudflare's server processing node. No device-identifying identifiers or credentials are shared. You can disable AI Mode at any time to remain 100% local.
4. Essential Session Cookies
We use essential cookies strictly to verify your active login status and maintain your secure dashboard access session. We do not use third-party tracking or advertising cookies.
5. User Rights
Under GDPR, you retain full rights of access, rectification, portability, and deletion of your compliance workspace records. To exercise these rights or request account closure, contact us at info@cygnus.health.
🤖 MDR Bot
Ask me about MDR, ISO 13485, clinical evaluation, GSPR, or CE certification. Enable AI Mode with your membership passcode for Cloudflare-powered answers.