Solutions — fixed-scope package
Compliance-Ready SDLC
Your development process, rebuilt so an auditor can follow it: requirements traceability, risk-classed testing, SBOMs, and release documentation — designed to support IEC 62304 without grinding your team to a halt.
What's in scope
- Assessment of your current process against IEC 62304-shaped expectations
- SDLC design: requirements, risk classification, traceability, and change control
- Tooling setup in your stack (issue tracker, CI/CD, test management, SBOM generation)
- Templates for the recurring documents: plans, records, release notes
- A pilot: one real feature shipped through the new process with your team
What you get
- A written SDLC your engineers actually follow — because they helped shape it
- Traceability from requirement to code to test, generated from your tools, not spreadsheets
- Automated SBOM and dependency-vulnerability reporting in CI
- Document templates filled in once, correctly, as worked examples
- A gap list with honest effort estimates for whatever remains
Timeline shape
- 01
Assess
We read your repos, pipelines, and docs, then interview the team. Output: a gap analysis you could hand to an auditor today.
- 02
Design & tool
Process designed with your leads; tooling and templates wired into the systems you already use.
- 03
Pilot & prove
One real feature through the full process, generating the first complete evidence trail.
What we need from you
- — Access to your repositories, CI/CD, and issue tracker
- — Your engineering leads’ participation in design sessions
- — Your RA/QA contact — regulatory strategy stays with them, and we align to it
- — One candidate feature for the pilot
Make the audit trail a byproduct, not a project.
Bring us an integration problem, a device fleet, or a product idea — we will come back with an approach, not a slide deck.