ACCESS TO MARKET · EU MDR · US FDA · CHINA NMPA

Your next market.
A clear strategy.

Bringing your medical device to a new market takes more than a submission.
It takes a shared view of the regulatory pathway, clinical evidence and quality system.

SYBEY connects these priorities with your business ambitions, with a particular focus on US manufacturers entering Europe and European manufacturers expanding into the United States.

Explore your next market ↓

TWO MARKETS. ONE CONNECTED PERSPECTIVE.

Where do you want to grow?

Start with your destination. Build a strategy around your device, your evidence and your organisation.

🇺🇸 US MANUFACTURERS → 🇪🇺 EUROPE

Make EU MDR part of
your growth strategy.

You have a device and an ambition for Europe. SYBEY helps you understand what needs to be in place and where to focus your efforts.

  • Assess your EU MDR pathway and regulatory gaps.
  • Align clinical evidence and evaluation planning with your European strategy.
  • Strengthen quality processes, documentation and audit preparation.
  • Define priorities for your teams and leadership.

A coordinated view of the work ahead, from evidence gaps to execution priorities.

Discuss your European strategy ↗

🇪🇺 EUROPEAN MANUFACTURERS → 🇺🇸 UNITED STATES

Approach the US market
with a clear FDA strategy.

Expanding into the US starts with understanding how your existing work fits the market you are entering. SYBEY brings FDA experience to that assessment.

  • Assess the regulatory pathway for your device and intended use.
  • Identify gaps in your submission plans and supporting evidence.
  • Align quality processes and documentation with your US objectives.
  • Prepare your organisation for inspection and implementation priorities.

A focused US market plan that connects regulatory requirements with business decisions.

Discuss your US strategy ↗

🇨🇳 CHINA · NMPA

Bring China into
your global strategy.

China requires a dedicated market-entry approach. SYBEY draws on its founder’s experience spearheading NMPA market entry to help you assess your pathway, identify evidence and documentation gaps, and structure your submission priorities.

We connect that work with your wider quality, regulatory and clinical strategy, so your next market fits into a coherent international plan.

Explore your China priorities ↗

SENIOR EXPERIENCE. INTERNATIONAL PERSPECTIVE.

Advice grounded in leadership
and hands-on delivery.

SYBEY draws on its founder’s experience before establishing the consultancy.

30+ years

Quality, Regulatory & Clinical

Experience with high-risk Class IIb and III medical devices, combining executive leadership and practical implementation.

80+ countries

International submissions

Oversight of global regulatory submissions, alongside leadership of EU MDR transition, US FDA and China NMPA market entry.

Executive perspective

Decisions beyond the dossier

Executive Committee and PRRC experience, with FDA inspection and quality-system integration responsibilities.

Explore our track record ↗

FROM AMBITION TO PRIORITIES

A practical starting point.

  1. 01

    Understand your position

    Your device, intended use, target markets and the work already completed.

  2. 02

    Identify what matters

    The regulatory, clinical and quality gaps that should inform your next decisions.

  3. 03

    Define the next steps

    A focused scope of support, with priorities and sequencing matched to your organisation.

YOUR DEVICE. YOUR AMBITION. YOUR NEXT MARKET.

Let’s discuss where
you want to go.

Tell us about your device and target market.
We’ll explore the priorities together.

Discuss your market access strategy ↗