Life sciences & medtech

The starting point

A medtech start-up developing software as a medical device, with a quality management system in documents, code in Git and an upcoming audit.

1. 🔎

   1 · Set up

   The team uploads the QMS procedures, the regulatory roadmap and the product description. The research recommends Compliance with the Validation Engineer, Software, Security and a Board that tracks the regulatory milestones.

2. 🔌

   2 · Take over the infrastructure

   The repositories move into the company’s own Git server, so code, reviews and validation evidence live in one place. Regulatory and supplier logins are stored per team in the vault.

3. 🧠

   3 · Take over the AI

   Agents that work on confidential design documents use a self-hosted or EU-hosted model; the model and reasoning effort are set per agent and visible to the auditors.

4. 🚀

   4 · Run the company

   Developers work through reviewed pull requests, the Validation Engineer documents tests against requirements, the Compliance Officer maps procedures to the regulations and the Risk Manager keeps the risk file. The audit becomes a review of what already exists.

The companies in these use cases are illustrative examples, not customer references. Features marked “planned” are being built.