Lumis blog posts
Integrating Service Provider Management and Risk‑Based Quality Systems under ICH E6(R3)
Delegating with oversight empowers responsible outcomes. By integrating rigorous service provider management with a cross‑functional, risk‑based quality management system, sponsors can fulfil their oversight duties in alignment with ICH E6(R3). This article outlines practical “to‑dos” for ensuring compliant trial conduct, participant safety, and data integrity.
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Navigating the Labyrinth: The CE-Marking Challenges for AiMD and SaMD in the EU
The European Union’s Medical Device Regulation and the new Artificial Intelligence Act introduced a seismic shift for medical device companies. For developers of Software as a Medical Device (SaMD) and, specifically, Artificial Intelligence Medical Devices (AiMD), obtaining the coveted CE mark has become significantly more complex.
Navigating the Labyrinth: The CE-Marking Challenges for AiMD and SaMD in the EU Read more
How Small Medical Device Companies Can Successfully Go Global
Global expansion for a medical device SME isn’t about simply selling a product in a new country; it’s a strategic undertaking that requires a series of critical decisions. Here are key decisions a medical device SME should make before going global.
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Global In-Country Representation: Convert Your Global Ambition to Global Reality
Navigating the complex landscape of medical device regulations across different countries can be a significant challenge for any company. To help our clients overcome these challenges, we are excited to announce the expansion of our in-country representative services to include key markets worldwide.
Global In-Country Representation: Convert Your Global Ambition to Global Reality Read more
Why You Need a Legal Representative for Clinical Trials in Europe
If your company is based outside the EU or EEA and you’re planning to conduct a clinical trial in Europe, there’s one thing you absolutely need to have in place before you get started: a legal representative. Here we explore the reasons for this and the options available.
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A Vigilant Ally – How Authorised Representatives Support Vigilance Activities
For medical device manufacturers outside the EU, Authorized Representatives are crucial for navigating the complexities of the MDR and IVDR. Authorised representatives provide essential support for vigilance activities and play a key role in supporting CAPA processes. Authorised representative involvement strengthens compliance and communication, allowing manufacturers to focus more on innovation whilst maintaining the highest level of safety and performance.
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Beyond Compliance: Transform Your Authorized Representative into a Strategic Partner
Authorised Representatives (EC-REP) can be strategic partners and not just a compliance necessity. A good EC-REP provides regulatory insights, strengthens supply chains, supports post-market activities, and offers access to expert networks. Therefore, choosing the right EC-REP is crucial for EU market success.
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Lumis Is Launching a New Authorised Representative Service
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.
Lumis Is Launching a New Authorised Representative Service Read more
Trends in Outsourcing Clinical Trials: A Comprehensive Overview
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
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.