EU MedTech Pre-Market Clinical Study Crash Course

Donawa Lifescience EU MedTech Pre-Market Clinical Study Crash Course

A 5-day, self-paced course and masterclass designed for sponsors and study teams who want to plan and execute EU pre-market clinical investigations with confidence and precision.

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What You’ll Learn

Before a single patient is enrolled, the success of a clinical investigation depends on how well the study is planned.

This course breaks down every step of that planning process—helping you understand how MDR 2017/745, ISO 14155:2020, and MDCG guidance documents work together in practice.

By the end of the course, you’ll have a clear map of what must be done, when, and by whom to keep your investigation compliant and on schedule.

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Webinar Replay — October 29, 2025

Watch the full masterclass “Initiating Pre-Market Clinical Investigations in the EU” with Donawa Lifescience experts Daniela Karrer and Matteo Mosso. The session walks through the practical realities of designing and launching EU pre-market studies under MDR 2017/745.

Slide Deck — Complete Presentation

Download the slide deck used in the live session, featuring all visual references, regulatory pathways, and examples discussed during the masterclass. Ideal for quick reference or internal training.

Five-Lesson Email Course + Resource Library

Access five concise daily lessons covering every stage of pre-market study planning—from regulatory mapping to budgeting and study conduct. Includes downloadable MDCG references, EU regulations, and templates in PDF format.

Ready to begin your next clinical investigation with clarity?

Ready to begin your next clinical investigation with clarity?Enroll in this 5-day course and gain the frameworks, tools, and documents needed to start your EU pre-market study the right way.

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You’ll Learn How To:

Align study planning with MDR 2017/745 and ISO 14155:2020
Select and qualify investigators who can deliver reliable data
Prepare compliant submission packages for multiple EU Member States
Budget and resource effectively to prevent mid-study disruption
Manage the operational realities that begin after first patient in