Fund It, Build It, Certify It: A MedTech Startup's Roadmap to Market

    A MedTech Startup's Roadmap to Market

    🕐 15:00 CET / 14:00 GMT / 09:00 EST

    Bringing a MedTech product to market is not only a regulatory challenge. It is a strategic, operational and financial one. Under MDR, compliance is not a final step that comes right before submission. It shapes product and company decisions from day one, and a weak regulatory or quality foundation delays timelines, increases burn rate and reduces investor confidence.

    In this session, QbD Group and Capital Cell bring together the two forces that decide whether a MedTech startup makes it to market: funding and regulation. You will see how the two are interconnected, why investors expect a credible regulatory strategy, not just a promising prototype, and what needs to be in place at each stage of the journey from idea to CE marking and beyond.

    This QbD Group initiative in the European MedTech ecosystem is designed to give European early-stage MedTech companies a clear, practical roadmap to a fundable pathway to market.

    What You'll Learn

    • Why funding and regulation are two sides of the same coin, and what investors actually look for when assessing regulatory readiness before a Series A or B round
    • How to finance your regulatory journey, from QMS setup and technical documentation to Notified Body fees and post-market surveillance, including the role of grants and public funding
    • The 8-step regulatory roadmap every MedTech startup must navigate, from product definition and classification, through QMS, design controls and clinical evidence, to technical documentation, CE marking and post-market obligations
    • Where early decisions make or break timelines, and the common regulatory and quality gaps that lead to costly redesign, rework and lost investor confidence
    • How to build multi-market from day one, positioning around ISO 13485 and MDR so you are also ready for FDA (QMSR) and MDSAP markets
    • Why CE marking is a milestone, not the finish line, and how to plan and budget for ongoing post-market surveillance from the start
    • Why it's inefficient for Venture Capital to invest small amounts in early-stage companies, and why you should look for money elsewhere
    • Investment in biotech startups vs. playing the lottery: similarities and differences, and why it matters to your fundraising strategy
    • How to structure an early-stage round for your startup: from lead investor to subsidies and everything in between

    About Capital Cell

    Capital Cell

    Capital Cell is the world's leading alternative investment platform for early-stage biotech and life science companies. Selected by experts and backed by visionaries, Capital Cell connects investors with high-impact opportunities to shape the future of health, one investment at a time.

    Performance to date:

    • 170+ completed funding rounds
    • €162M total invested
    • 2.7x portfolio value

    For MedTech startups, Capital Cell brings the investor perspective on what it takes to fund the regulatory journey, from QMS setup and technical documentation to Notified Body fees and post-market surveillance.

    Who Should Attend

    This webinar is built for European early-stage MedTech startups and scale-ups (Medical Devices under MDR) that are pre-CE or preparing for their first EU submission, and for anyone influencing those decisions:

    • CEOs, founders and COOs
    • VPs and Heads of Regulatory Affairs
    • Heads of Clinical Affairs
    • QA Managers, Software and Technical Leads (SaMD)
    • Investors and Innovation Managers

    Speakers

    Anne-Sophie Grell

    Business Unit Manager RA MD, QbD Group

    Anne-Sophie anchors the session with the QbD Group roadmap, walking through the regulatory and quality path from idea to market. She covers what startups need to have in place at each stage, from the classification and QMS decisions that shape everything downstream, to clinical evidence, technical documentation, CE marking, and the post-market obligations too many teams underestimate.

    Daniel Oliver Uriel

    Founder, Capital Cell

    Daniel brings the investor lens on the funding side. He explains what investors look for in regulatory readiness, how funding and compliance are interconnected, and how startups should think about financing their regulatory journey, including grants, public funding and the Barcelona ecosystem as a launchpad for European market access.

    Daniel Oliver Uriel

    Laia Cruz (Moderator)

    Sales Director Spain, QbD Group

    Laia moderates the discussion, connecting the regulatory roadmap with the funding perspective and bringing in questions from the audience.

    Laia Cruz

    Partner

    This webinar is organised by QbD Group together with Capital Cell.