Fractional support for regulatory strategy, clinical validation, and product R&D.
Women deserve real, validated health solutions.
I can help you build yours.
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 project-based or fractional support.
Build evidence-backed products that clinicians will trust, and users will love.
Services
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Navigate regulatory pathways with pragmatism and confidence. I can help you assess device classification, risk, and evaluate potential faster pathways to market.
• EU-MDR compliance and CE mark
• FDA registration and 510(k) premarket clearance
• Initial importer or authorized representative designation
• QMS implementation
• FSA-HSA reimbursement
• Crisis management and support
• Compliance with international standards (ISO13485, IEC60601, IEC10993, ISO 14971, ISO 62304, ISO 14155) -
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.
• Clinical trial design and execution support
• Publication strategy and manuscript development
• Research partnership-building with academic institutions
• Clinician-facing materials and training -
Product development strategy from 0 to 1: I can help you define your proof of concept, early prototyping strategy, verification and validation testing plan, and usability.
• Medical device design and development strategy
• Prototyping and validation protocol development
• Iteration and analysis
• Problem-solving -
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.
• Strategy sessions
• Pitch development and support
• Scientific communication and messaging
• Board leadership
What People are Saying
“At a critical stage in our journey, Erica immediately grasped the challenges we were facing and brought clarity and direction. Her ability to apply her experience to deliver bespoke, highly relevant advice was invaluable.”
“Most remarkable are her human skills: a leader you wish to follow due to her empathy and impactful communication skills.”
“When Erica highlights something that could be done better, it is never for the sake of criticizing but keeping the growth of the company at heart. She is a force for change, for the better.”
“She has the rare capacity to make science accessible.”
“I have had the pleasure of discovering your multiple talents, scientific obviously, but also strategic thinking, storytelling, panel facilitation... I have truly enjoyed all our discussions as I always learned something.”
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.