🛡️ From AI prototype to IEC 62304 medical device — in weeks, not years
Asepti is a compliance-first platform that lets you ship certified medical functions fast, without the regulatory drag. Skip the paper trails, re-engineering loops and endless audits. We turn your code into compliant, deployable medical-grade capsules — in days.
Compliance is killing your runway.
Building an AI-based diagnostic function? Before you see any patient or revenue, you’ll likely lose:
- ⏳ 6 to 12 months wrestling with IEC 62304 & ISO 13485
- 💸 30% of your seed cash burned in “compliance debt”
- 🔁 Complete refactoring of your code just to meet audit standards
- All this, before you even start certifying.
🧬 The Asepti Solution
An aseptic layer between your business logic and the regulation jungle
With Asepti, your dev team just provides:
- ✅ The algorithm, inside a preset Docker container
- 📥 Input specs (fields, files, formats)
- 📤 Output specs (structured results, files, reports)
- 🔁 A few real test cases
🧬 What we provide
Asepti automatically generates these assets for you
- 🚀 A secure, segregated runtime
- 📚 A complete IEC 62304 doc set
- 🧾 Hosted fields or HL7 interfaces
- 🔁 Traceable, auditable deployments
⚙️ How it works?
Your function → GitHub → Asepti CI/CD → Hosted, certified endpoint + Full documentation
- Works with Python, Java, JS, C/C++
- Supports synchronous, async & real-time calls
- Works with your stack: GitHub, GitLab, Jira, HL7
- Hosted form fields obfuscate PHI from your frontend
- Change something? Push → Asepti → New version in <1h
How is it for?
Seed / Series A startups
Seed–Series A startups, especially building diagnostic AI
Medtechs modernizing legacy code
Super fast page load with Tailwind CSS and super fast site building with Hugo.
Compliance consultants
Compliance consultants looking to white-label automation
"Moving to Asepti reduced our go-to-market time, allowing our company to deploy new diagnosis software in less than 4 weeks where our compliance consultancy firm announced several months of work."
