Between medtech and wellness,
the edge of regulatory science.

A boutique agency for novel healthtech that doesn’t quite fit the rules.

Get a regulatory second opinion

Proud enablers of women’s health pioneers

  • https://helloclue.com/

    Digital health app for period and fertility tracking with conception and contraception modes

    SaMD
  • inne.io

    Hormone monitoring IVD self-test kit for fertility diagnostics and reproductive health

    IVD
  • https://www.gitticonsciousbeauty.com/

    Plant-based nail polish and cosmetics

    Cosmetics
  • Hershey logo with the word 'Hershey' next to a circular emblem containing the initials 'EH'.

    Natural supplements for fertility and PCOS symptoms

    Supplements
  • askovum.com

    AI health assistant and journal designed for womankind

    AI

With a tech-forward and tailored approach to compliance,
we translate ambiguity and design your compliance assets

So you can pioneer what’s next — and close health gaps faster

Our specialties

1. Is it a medical device?

We help you design your product and marketing claims to fit your strategy and available evidence, and to understand the opportunities and limitations in either scenario.

Claims clarity and early design strategy

    • Medical devices

    • Digital health and SaMD

    • AI/ML-enabled devices

    • Combination products

    • Wearable-connected apps

    • Cosmetics

    • Food supplements

    • Health trackers

    • Natural health products

    • Clinical studies

    • Clinical evaluation

    • Real World Evidence (RWE)

    • Post-market surveillance

Our take on borderline products

2. Can speed meet quality?

We create assets not processes — built to scale with AI and to work for your team. We draw the line of what must and could be done, to fit your risk tolerance and needs.

Quality operations that scale with your ambition

    • ISO 13485 / 9001 — Quality Management System

    • ISO 14971 — Risk Management

    • IEC 62304 — Software Development Lifecycle

    • IEC 62366 — Usability Engineering / Human Factors

    • ISO 27001 / 27002 Information Security

    • ISO 42001 AI Management System

    • EU AI Act

    • ISO 22716 Cosmetics GMP

    • Food supplements HACCP

How we think about risk

3. Which market next?

Whether you aim for market entry proof-of-concept or to access untapped regulated markets, we guide you with latest intelligence, global partners and an open mind.

Regulatory strategy without borders

    • EU MDR / IVDR CE mark

      • MDR Annex XVI

      • Borderline Manual

      • MDCG classification guidance

    • Notified Body / authority liaison

    • UK MHRA, FSA

    • SwissMedic

    • US FDA

      • General Wellness Policy for Low Risk Devices

      • Clinical Decision Support Software Guidance

      • 21 CFR

    • HealthCanada

    • Brazil ANVISA

    • UAE MOHAP

    • Saudi Arabia SFDA

    • Australia TGA

    • New Zealand Medsafe

    • Singapore HSA

Our market analysis for femtech

Our experts

  • Giulia Paggiola

    Giulia Paggiola

    Founder & CEO

    PhD in Chemistry

    14 years at the boundaries of life science innovation: femtech (ex-Clue), AI/ML devices, green pharma (ex-GSK), medical cannabis, cosmetics, supplements

    LinkedIn

  • Erica Perrier

    Erica Perrier

    Senior Consultant

    PhD in Nutrition and Exercise Science

    18 years at the interface between product R&D, clinical and regulatory leadership, in wellness (ex-Danone), fitness and healthtech (ex-Perifit), and as board advisor in femtech

    Linkedin

  • Markus Osterloh

    Markus Osterloh

    Senior Consultant

    PhD in Biology

    15 years across biotech, medtech and diagnostics, from oncology diagnostics (ex-Biofrontera), through to fertility (ex-Clue) and pathogen detection (Noscendo)

    LinkedIn

  • Arturo Sanchez

    Arturo Sanchez

    Consultant

    PhD in Biomedicine

    12 years at the edge between women’s health science and compliance, from researching at ETH, to IVD testing for endometriosis and AI validation

    Linkedin

  • Mylene Remolcoy

    Mylene Remolcoy

    Project Manager

    MSc in Innovation Management

    11 years at the intersection between R&D and quality operations in innovative food, sustainability and health industries.

    LinkedIn

Our manifesto

We know the pains of figuring out what has never been done before

We built our careers at the interface between wellness and healthcare, and at the fringes of technological advancement.

We too have faced the fear of regulatory uncertainty and the frustration of compliance that appears to slow you down.

The edges have taught us to be nimble, open, inquisitive. Not to surrender to the status-quo, but to listen with care and search for creative solutions in unexpected places.

The life science sector is tougher than ever

  • Technology moves way faster than regulatory science

  • Innovation blurs the lines between wellness and medical

  • Health gaps and stigmas require urgent attention

The edge is where innovation unfolds

In ecology, “edge effect” refers to the extraordinarily rich and diverse evolution that happens at the boundary between ecosystems.

Likewise, we see the most exciting, promising - and complex - innovation emerging at the edge of the medtech ecosystem. That’s where you find us.

Our closest partners

Let us know what you do and what you are struggle with. We look forward to finding solutions together.

Tell us more

Book a 30min intro call

hello@edgecompliance.co