We’ve successfully completed our ISO 13485:2016 surveillance audit, with zero findings and a recommendation to continue certification. Of course that’s good news for us. But more importantly, it’s great news for the startups and scale-ups we work with. Because this result is not about a certificate on the wall. It’s independent proof that the way we organise quality actually works, in real projects and under real conditions.
Proof, not promises
During the audit, our day-to-day way of working was reviewed in detail: how we set up projects, manage documentation, handle data, control changes and assign responsibilities. The clean outcome confirms that our quality framework is consistent, controlled and audit-ready. In short: the quality system we rely on ourselves stands up to external scrutiny.
The same quality, now available to you
That’s exactly what Quality Management as a Service is built on. Instead of asking startups to build a full quality system from scratch, we make our own ISO 13485-aligned way of working available to others. Same principles. Same discipline. Applied pragmatically to support your development. What we do for ourselves, we’re just as happy to do for you.
Why this matters for startups
Working with us on quality means building on something that has already proven itself. It reduces friction around documentation and traceability, supports regulatory readiness, and lets teams focus on development instead of paperwork.
👉 Discover Quality Management as a Service
Interested in making quality your advantage?
For more information on SBMC’s Quality Management services – including rates:
