SERVICES
Two ways of working, and a limited number of conversations at any time. Each page below says what the work actually involves — and, as usefully, what it does not.
A small number of early founders are mentored at no cost each year. It is meant for people at the very beginning — before funding, before a regulatory plan, sometimes before a prototype — where one well-aimed conversation can change the direction of the next year of work. No fee, no equity, no obligation.
How mentoring works →Regulatory strategy for software as a medical device is the work of deciding early what your product legally is, and building the quality system and evidence that follow from that answer. It covers qualification, classification, the certification route, and the QMS structure needed to survive an audit — while those decisions are still cheap to change.
More on regulatory & samd strategy →A limited number of advisory conversations are taken on at any time.
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