Build evidence-based products that your consumers trust.
Fractional support in regulatory strategy, clinical validation, and product development.
Evidentia Consulting helps FemTech and women’s health innovators — from first-time founders to established companies — build trustworthy, effective products, get them to market, and accelerate global adoption through flexible, expert support.
Services
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Cut through the fluff and design products (and features) that women actually want to use. I can help you define your plausible mechanism of action, capitalize on existing scientific evidence, and design your product development strategy to build an effective device.
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Set your clinical validation strategy and build credibility with scientific and healthcare stakeholders. From Phase I trials to Real World data collection, I can help you build evidence that your device works, and communicate it effectively to win over healthcare providers and key stakeholders.
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From CE mark to 510(k) to meeting ISO standards, navigate regulatory pathways with pragmatism and confidence. I can help you assess device classification, risk, and evaluate potential faster pathways to market.
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Are you looking to reinforce your Board of Directors, Advisory Board, or do you have one-off advising needs? I can build a package that works for you.
Let’s get to work.
Hands-on, operational expertise
Experienced in bringing FemTech medical devices from proof-of-concept and prototyping all the way to market approval, I bring real-world results, not theory. I can bring senior-level ownership execution to support your growing team as a fractional CXO (technology, science, regulatory).
Strategic advisory
If you have your team in place, but need help building your roadmap and strategy, I can act as your sounding board or sparring partner to crash-test your ideas and assumptions, assess risk, and build a clear path forward.
Worldwide reach
Paris-based and bilingual in English and French, with seamless navigation of US, Canadian, and EU cultures and regulatory landscapes, I bring a global perspective to your innovation, wherever you are based.
Case Studies in FemTech Innovation
Let’s build something amazing together.
Not sure how to get started? Get in touch.