At the frontiers of healthtech.
The edge of regulatory science.

With a progressive and holistic approach to quality and regulatory compliance we enable life science innovators to thrive globally between medtech and wellness markets

Giulia Paggiola

Founder & Principal

PhD in Chemistry
13 years at the boundaries of life science innovation: pharma (ex-GSK), medical cannabis, wellness, digital health (ex-Clue), AI/ML devices
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Felix Spoerl

Consultant
MEng Biomedical Engineering
12 years at the frontiers of technology from wearable prosthetics (ex-Ottobock) to biomarkers (ex-mySugr) and symptom checkers (Ada)
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Erica Perrier

Consultant
PhD in Nutrition and Exercise Science
18 years at the interface between product R&D and regulatory in wellness (ex-Danone), fitness and healthtech (ex-Perifit)

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Markus Osterloh

Consultant
PhD in Biology
15 years across medtech and diagnostics from oncology biotech (ex-Biofrontera) to fertility SaMD (ex-Clue) and pathogen IVD (Noscendo)
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Mylene Remolcoy Yucra

Quality & Operations Associate
MSc in Innovation & Entrepreneurship
11 years at the intersection between R&D and quality operations in food, wellness and healthtech (ex-Clue)
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Our specialties

We love projects that cross sector boundaries, challenge conventions, and drive social impact.

See the dropdown list for our core competencies. For what’s outside of our wheelhouse, we rely on trusted partners who are aligned to our ethos whom we’d be happy to recommend.

Positioning, beyond milestones
- Strategy and classification
- Claims and labelling
- Submission
- Authority liaison
- Inspection readiness
- Regulatory monitoring
- Device registrations
Understanding your options
(Cosmetic, Wellness, Wearables, Digital Health)
- Labelling strategy
- Consumer vs medical pathway assessment
- Applicable GMP and regulations (EU & US)
- Product documentation compliance
- Microbiological risk assessment ISO 29621
- Product registration
Crafting quality that truly fits your org
- QMS design
- eQMS selection
- SOP writing and optimisation
- Training
- Audits
- CAPA support
- Software validation
- ISO certification
Integrating quality into product R&D
- Medical writing (GCP, ISO 14155)
- Supplier evaluation
- Post-market surveillance
- Post-market clinical follow-up
- Vigilance assessment
User-centric clinical and regulatory outcomes
- Risk Management ISO 14971
- Usability Engineering IEC 62366-1
- Information security ISO 27001 / IEC 81001-5-1
- FDA and MDCG cybersecurity guidelines
- Active devices IEC 60601 series
- Biocompatibility ISO 10993
- Pre-certification audits
A stress-free compliance resource
- Board advisory
- Fractional & interim leadership
- Hiring strategy and support
- Team coaching
- Tactics and project management
- Quality Management Representative (QMR) - ISO 13485
- Person Responsible for Regulatory Compliance (PRRC) - EU MDR & IVDR

Reach out to know more or partner up

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 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.

What worked before within one silo may not work any longer. Guidelines are still to be written. We must look across borders with an open mind.

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

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