What Founders Underestimate Early On
Watch the on-demand recording: Egbert Smit (CEO of MLA Diagnostics) and Annelies Rotthier (QbD Group) unpack the clinical evidence decisions that trip up oncology diagnostic startups — and how to get them right the first time.
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Do you need compliant clinical evidence for your IVD device? Our IVD experts are happy to support you in your IVD Performance Evaluation Studies.
In oncology IVD, the decisions you make earliest often cost you the most later. Intended use assumptions, sample strategy, study endpoints, these choices quietly shape your regulatory path, your timeline, and your credibility with investors.
Yet most founders only discover this when they're already locked in.
In this 60-minute session, Egbert Smit, CEO of MLA Diagnostics, and Annelies Rotthier from QbD Group unpack the clinical evidence decisions that trip up oncology diagnostic startups, and how to get them right the first time. Egbert brings the founder's perspective from building a melanoma risk stratification diagnostic. Annelies brings the strategic lens on study design and IVDR readiness.
No generic CRO talk. Just the early-stage thinking that separates fast, credible paths to market from expensive detours.
Learn from the best
Two experts who've seen both sides of the oncology IVD journey — the founder's reality and the regulatory strategy that makes or breaks it.
CEO, MLA Diagnostics
Life sciences leader with 20+ years of science and business experience. (Co-)founder of several IVD businesses and currently leading oncology IVD venture MLA Diagnostics (Maastricht) and cardiovascular disease IVD venture PERSUASIVE (Utrecht).
Business Unit Manager IVD CRO, QbD Group
IVD Clinical Evidence and Medical Writing. IVD Product Development and IVDR Compliance. Strategic leadership & Consultancy.
Keep watching
On Demand WebinarIn this 60-minute session, Egbert Smit (CEO of MLA Diagnostics) and Annelies Rotthier (QbD Group) unpack the clinical evidence decisions that trip up oncology diagnostic startups — and how to get them right the first time.
Watch now
On Demand WebinarJoin our webinar to explore the essential clinical evidence needed for success, including investigations, literature reviews, technical performance, and the use of similar devices. We’ll discuss the critical role of clinical validation starting from the design phase and guide you on how to compile the necessary evidence to meet MDR requirements.
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On Demand WebinarLearn how to design and deliver successful clinical performance studies under IVDR. Explore strategic, regulatory, and operational aspects with expert guidance.
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