Webinar On Demand • Introduction to Medical Devices in the EU Regulatory Landscape

Bureau Veritas organizes a new webinar to provide essential guidance to medical device manufacturers, suppliers, SMEs, start-ups, and organizations involved in the medical device supply chain navigating the complex European regulatory environment.

This introductory session addresses the critical market needs identified by Swiss medical device companies, particularly the lack of knowledge in regulatory frameworks and market access topics that often lead to incorrect prerequisites for market entry. In fact, recent surveys reveal that Swiss medical device companies are struggling with regulatory compliance:

• Many start-ups and SMEs begin with incorrect prerequisites
• Widespread lack of understanding in regulatory pathways
• Wrong assumptions leading to delayed market entry

The focus of this webinar will be on MDR 745/2017 and ISO 13485:2016 certifications. Participants will learn who should implement ISO 13485, the certification pathway, key benefits, the role of notified bodies in conformity assessment procedures, including compliance demonstration, process improvement, and stakeholder confidence enhancement.

SPEAKER

Alessio Quaranta, Medical Device Product Development Leader - Bureau Veritas

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