A Swiss startup was struggling to explain their regulatory plan to investors. Within 3 weeks of working with us, they had a clear roadmap, budget, and timeline—leading to successful closure of their next funding round.

An early-stage wearable device company needed to tailor their existing ISO 13485 QMS without hiring a dedicated RA/QA team. We transformed the QMS to a lean QMS that passed audit and reduced ongoing compliance workload.

A founder-led team was overwhelmed by EU MDR requirements. Our team provided hands-on guidance, helping them define their classification, design a compliance strategy, and avoid 9+ months of wasted effort on the wrong documentation path.