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

With a progressive and holistic approach to regulatory compliance we enable life science innovators to thrive globally and at the edge between medtech and wellness

Our specialties

Medical vs Wellness Frontiers -
Claims and Clinical Strategy

We help you choose the right marketing claims for your strategy and data, and to understand the opportunities and limitations in either scenario.

  • Digital health and SaMD

  • AI/ML enabled devices

  • Wearable-connected apps

  • Cosmetics

  • Food supplements

  • Medical cannabis and herbal medicines

  • Medtech

  • Combination devices

Quality Ops: Balancing Guardrails with Value Generation

We design assets not processes, which can scale with AI and for AI. We draw the line of what must and could be done, to fit your risk tolerance and needs.

  • ISO 13485 / 9001 Quality Management System

  • IEC 62304 Software Development Lifecycle

  • ISO 27001 Information Security

  • ISO 42001 AI Management System

  • EU AI Act

  • Good Manufacturing Practice (GMP)

  • Compliance workflows and AI agents

  • Readiness, auditing, optimisation

Regulatory Strategy
Without Borders

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.

  • European Union: MDR / IVDR CE mark

  • United States: FDA

  • United Kingdom: MHRA, FSA

  • Switzerland: SwissMedic

  • Australia: TGA

  • Canada: HealthCanada

  • Brasil: ANVISA

  • UAE: MOHAP

Our services


Fractional Regulatory Compliance Leadership

A stress-free compliance resource. Whether it’s board advisory, interim leadership, external representation (PRRC) or hands-on project execution - we join and elevate your team.


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.


Project-basis

We design and deliver short- to long-term compliance projects to meet your goals. It may be trainings, eQMS implementation, design changes or clinical studies.

Our experts

Our journey

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.

The edge is where innovation unfolds

We are proud to have enabled female health pioneers

We partner with

Reach out

Find a time slot directly on our calendar below or write us a message via the form or email.

We look forward to hearing out your needs.

hello@edgecompliance.co