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The latest from Lumis’ Content Hub
Lumis Is Launching a New Authorised Representative Service
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Are you a non-EU medical device manufacturer? If so, Lumis could be your gateway into Europe via our new authorised representative service.
In accordance with Article 11 (1) of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), any manufacturer not established within an EU Member State must designate an Authorized Representative to market their devices within the EU. …
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Trends in Outsourcing Clinical Trials: A Comprehensive Overview
Outsourcing in Clinical Trials
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Outsourcing clinical trials has become an increasingly prevalent trend not only in the pharmaceutical industry but also increasingly at small to midsize biotech and medical device companies. As the complexity of drug development and regulatory requirements continue to grow, companies are turning to specialized external partners to conduct clinical trials more efficiently and cost-effectively. …
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Overview of the Orphan Designations Webinar
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This webinar is divided into several sections, either focusing on different aspects of orphan designation (OD) in key global markets or rare disease trials. The goal is to provide attendees with a comprehensive understanding of the benefits, application processes, and strategic implications of securing orphan designations globally. …