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