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.

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Girl in front of brick wall painted with FOR WOMEN.  FemTech consulting research development regulatory

Services

  • 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.

  • 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.

  • 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.

  • 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.

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Let’s get to work.

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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

  • Black and white target with concentric circles and numbers, with an arrow hitting the bullseye. FemTech research and scientific consulting

    Improve device effectiveness

    You know your device improves health, but lack the proof—or worry some features may not meet user needs.

  • Blue circular traffic signs with white arrows pointing left and right, mounted on a white wall. FemTech regulatory consulting.

    Unlock markets and reimbursements

    Eyeing a global launch but unsure how to navigate regulations or unlock reimbursement opportunities?

  • Seven white floating shelves against an orange wall, arranged in an ascending diagonal line from left to right. Femtech network building and outreach.

    Gain healthcare provider trust & referrals

    Healthcare providers will guide users—only if your product earns their trust.

Let’s build something amazing together.

Not sure how to get started? Get in touch.