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Bosanski MVP Lab
Rapid MVP development for MedTech and healthtech ideas — from concept to a testable prototype, built with ISO 13485 and MDR requirements in mind from day one.
Built around how your organization actually works
QualityCert structures management systems consulting by organization type, because a manufacturer, a distributor, and a pharmacy carry very different regulatory obligations.
From concept to a testable MedTech prototype
Built with ISO 13485 and MDR requirements in mind from day one, not retrofitted later.
MVP Lab is the productized front end of QualityCert's product development support — for MedTech and healthtech ideas that need a fast path from concept to a testable prototype, without losing sight of the regulatory pathway the finished product will eventually need to follow.
Keeping basic design control and regulatory awareness present from the earliest sketches means the resulting prototype doesn't need to be rebuilt from scratch to become audit-ready later — it just needs to be built out further.
What we help you build
- A defined concept and intended use before development starts
- A working, testable prototype rather than a slide deck
- Early identification of the applicable regulatory pathway
How we keep it audit-ready
- Basic design control practices from day one
- Documentation kept in a state that can be expanded into a full technical file
- Coordination with the same external specialist network used for larger projects
Outcome
- A tested prototype ready for user feedback or investment conversations
- A head start on the regulatory documentation a real product will eventually need
- A clear view of what a full development program would involve
Ready to build a system that works for your organization?
Tell us about your organization type and where you are today — we'll recommend the right starting point.
Book Intro Call