Between medtech and wellness,
the edge of regulatory science.
A boutique agency for novel healthtech that doesn’t quite fit the rules.
Proud enablers of women’s health pioneers
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![https://helloclue.com/]()
Digital health app for period and fertility tracking with conception and contraception modes
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![inne.io]()
Hormone monitoring IVD self-test kit for fertility diagnostics and reproductive health
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![https://www.gitticonsciousbeauty.com/]()
Plant-based nail polish and cosmetics
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Natural supplements for fertility and PCOS symptoms
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 choose the right marketing claims for your strategy and data, and to understand the opportunities and limitations in either scenario.
Claims clarity and integrated clinical strategy
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Medical devices
Digital health and SaMD
AI/ML enabled devices
Combination products
Medical cannabis
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Wearable-connected apps
Cosmetics
Food supplements
Health trackers
Natural health products
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Clinical studies
Clinical evaluation
Real World Evidence (RWE)
Post-market surveillance
2. Can speed meet quality?
We design 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
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ISO 13485 / 9001 Quality Management System
ISO 14971 Risk Management
IEC 62304 Software Development Lifecycle
IEC 62366 Usability Engineering / Human Factors
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ISO 27001 / 27002 Information Security
ISO 42001 AI Management System
EU AI Act
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ISO 22716 Cosmetics GMP
Food supplements HACCP
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
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EU MDR / IVDR CE mark
Notified Body / authority liaison
UK MHRA, FSA
SwissMedic
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US FDA
HealthCanada
Brazil ANVISA
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UAE MOHAP
Saudi Arabia SFDA
Australia TGA
New Zealand Medsafe
Singapore HSA
Our experts
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![Giulia Paggiola]()
Giulia Paggiola
Founder & Principal
PhD in Chemistry14 years at the boundaries of life science innovation: femtech (ex-Clue), AI/ML devices, green pharma (ex-GSK), medical cannabis, cosmetics, supplements
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![Erica Perrier]()
Erica Perrier
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)
Linkedin -
![Felix Spoerl]()
Felix Spoerl
Consultant
MEng Biomedical Engineering
12 years at the frontiers of technology from blood glucose management apps (ex-mySugr), prosthetics (ex-Ottobock) and digital symptom checkers (ex-Ada)
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![Markus Osterloh]()
Markus Osterloh
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)
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![Mylene Remolcoy Yucra]()
Mylene Remolcoy Yucra
Quality & Operations Associate
MSc in Innovation Management
11 years at the intersection between R&D and quality operations in innovative food, sustainability and health industries.
Working together
Fractional regulatory leadership
Your senior regulatory lead without the full-time hire. Whether it’s board advisory, interim leadership, representation (PRRC) or hands-on project execution - we join and elevate your team.
No overhead
Scalable support
Seamless fit
Retainer or day rate
On-demand advisory
The impartial second-opinion that can spare you from internal debates and costly mistakes. Whether regularly or occasionally, you can reach us at need.
Flexible and on short notice
Bundles or capped monthly hours
Founder mentorship
Projects & POCs
We design and deliver short- to long-term compliance projects to meet your goals. It may be a submission, an internal audit, due diligence or clinical study support.
Finite short-term projects
Proposal tailored to your request
Fully anticipated cost
Keynotes & Panel expertise
We are actively involved in the regulatory community and the frontiers of healthtech. Contact us for a fresh and tech-forward regulatory perspective.
Regulatory 101 talks
Regulatory perspective
Corporate training
Our manifesto
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.
We know the pains of figuring out what has never been done before
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.
Let us know what you do and what you are struggle with. We look forward to finding solutions together.
Tell us more
hello@edgecompliance.co