From Prototype to Certified Medical Software
π‘οΈ From AI prototype to IEC 62304 medical device β 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 β in days.
π§ The Problem
Compliance is killing your runway.
Building an AI-based diagnostic function? Before you see any patient or revenue, youβll likely lose:
- β³ 6 to 12 months wrestling with IEC 62304 & ISO 13485
- πΈ 30% of your seed cash burned in βcompliance debtβ
- π Complete refactoring of your code just to meet audit standards
All this, before you even start certifying.
𧬠The Asepti Solution
An aseptic layer between your business logic and the regulation jungle
With Asepti, your dev team just provides:
- β The algorithm, inside a Docker capsule
- π₯ Input specs (fields, files, formats)
- π€ Output specs (structured results, files, reports)
- π A few real test cases
We generate the rest:
- π A secure, segregated runtime
- π A complete IEC 62304 doc set
- π§Ύ Hosted fields or HL7 interfaces
- π Traceable, auditable deployments
βοΈ How it works
Your function β GitHub β Asepti CI/CD β 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 β Asepti β New version in <1h
π‘ Who itβs for
- π§ͺ SeedβSeries A startups building diagnostic AI
- 𧬠Medtechs modernizing legacy code
- π§βπ» Compliance consultants looking to white-label automation
From MVP to compliant Class B medical software β in under a month.
π° Pricing (starting point)
| Class | Platform Fee (year) | Per-Function Runtime | Doc + Storage Fees |
|---|---|---|---|
| A | β¬40,000 | Cloud + 10% | Cloud + 10% |
| B | β¬80,000 | Cloud + 15% | Cloud + 15% |
| C | β¬120,000 | Cloud + 20% | Cloud + 20% |
Need HL7 or Real-Time engine? Letβs talk.
π Ready to skip the 12-month delay?
Letβs talk. Weβll show you exactly how your algorithm becomes a certified product β in weeks, not years.
π Book a 20-min intro call β
(No sales BS. A real walkthrough of what it looks like to use Asepti on your project.)
β Why Asepti?
- π Full segregation between medical & non-medical software
- π Auto-generated IEC 62304 docs (dev plan, risk matrix, test reportsβ¦)
- β±οΈ <1h version release pipeline
- π¬ Hosted forms that see the data β your app doesnβt have to
- π‘οΈ Designed with ex-notified-body auditors
π Frequently Asked
Do I need to rewrite my code?
No. Just containerize your logic. Asepti handles the rest.
Can I use my CI/CD?
Yes. You push. We validate. You deploy.
What if I need human help?
Every client gets a high-touch onboarding. Weβre your compliance co-pilot.
π§ Our Vision
From prototype to patient-ready in weeks, not years.
Asepti is your fast lane to compliant, AI-powered healthcare software.