Breaking Into Europe: Regulatory and Market Access Essentials for Digital Health Companies

Regulatory and Market Access Strategy for Digital Health Companies in Europe

The European landscape for digital health solutions is evolving rapidly, with regulatory expectations becoming more rigorous and market access pathways increasingly structured. In this environment, ProductLife Group strengthens its position as a content leader, offering a dedicated webinar to support digital-health companies in building robust, evidence-based and region-aligned strategies for European entry.

The session provides a clear view of the requirements that shape successful market pathways and helps teams anticipate what authorities expect in terms of documentation, compliance, and evaluation readiness.

Key topics of the session

• the main regulatory requirements for digital health solutions in Europe

• the foundations of a coherent market access strategy across EU markets

• how to structure a complete and inspection-ready dossier

• recommendations for compliance, documentation governance and data control

• real-world case studies showing how integrated CMC-regulatory planning accelerates time-to-file

Speakers

The session will be led by PLG experts with deep experience in regulatory and market access for digital health: Mariangela Prada, Karine Bonenfant, Samuel Buet

Webinar details

Register here