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id="hero-section" class="hero-section full-width"> <div class="hero-section-overlay"></div> <img class="hero-section-graphic" src="/wp-content/themes/lumis-child/dist/img/home-page-graphic-with-gradient-1.jpg" alt="" decoding="async"> <div class="hero-section-text wrap"> <h1 class="white-text">Representing your medical innovation.<br>Empowering your product development.</h1> </div> </div> <section class="home-introduction"> <p>At Lumis, we provide <strong>specialized legal representation and consulting services</strong> for small to mid-sized biopharmaceutical and medical device companies worldwide.</p> <p>Lumis is your gateway to Europe. We <strong>empower the development of your drug or medical device</strong> with tailored strategies, analytics and solutions, ensuring <strong>reduced time-to-market</strong> with realistic budgets and the highest quality standards.</p> <p>Partnering with Lumis gives you access to over 20 years of comprehensive expertise in consulting and managing international drug and medical device projects.</p> <p><a href="/lumis-international/">More about Lumis</a></p> </section> <section class="home-services-section full-width light-bg mb0"> <div class="home-services-section-container wrap"> <ul> <li> <h2 class="flash-dark-orange">Legal Services</h2> <figure class="intro-image"><img width="660" height="219" src="https://lumisinternational.com/wp-content/uploads/2025/02/justice-under-law.jpg" class="attachment-full size-full" alt="Justice under law inscription" decoding="async" fetchpriority="high" /></figure> <p>Lumis Legal Representation Services offers representation for small to mid-sized biopharmaceutical and medical device companies worldwide, allowing you to conduct clinical trials in Europe, Switzerland and the UK without a local presence.</p> </li> <li class="legal-service"> <figure> <a aria-label="Learn more" href="https://lumisinternational.com/eu-legal-representative-clinical-trials/"> <img aria-hidden="true" src="https://lumisinternational.com/wp-content/uploads/2025/02/legal-representative-simple.png" alt="" /> </a> </figure> <h3> <a aria-label="Learn more" href="https://lumisinternational.com/eu-legal-representative-clinical-trials/"> Legal representative clinical trials </a> </h3> <p>Your EU legal representative managing all relevant regulations</p> <span class="service-link"> <a aria-label="Learn more" href="https://lumisinternational.com/eu-legal-representative-clinical-trials/"> Learn more <svg aria-hidden="true"><use xlink:href="/wp-content/themes/lumis-child/svg-defs.svg#long-arrow-right"></use></svg> </a> </span> </li> <li class="legal-service"> <figure> <a aria-label="Learn more" href="https://lumisinternational.com/data-representative/"> <img aria-hidden="true" src="https://lumisinternational.com/wp-content/uploads/2025/02/data-representative-simple.png" alt="" /> </a> </figure> <h3> <a aria-label="Learn more" href="https://lumisinternational.com/data-representative/"> Data representation GDPR article 27 </a> </h3> <p>Your EU data representative aligned with relevant privacy regulations</p> <span class="service-link"> <a aria-label="Learn more" href="https://lumisinternational.com/data-representative/"> Learn more <svg aria-hidden="true"><use xlink:href="/wp-content/themes/lumis-child/svg-defs.svg#long-arrow-right"></use></svg> </a> </span> </li> <li class="legal-service"> <figure> <a aria-label="Learn more" href="https://lumisinternational.com/authorized-representative/"> <img aria-hidden="true" src="https://lumisinternational.com/wp-content/uploads/2025/02/authorized-representative-simple.png" alt="" /> </a> </figure> <h3> <a aria-label="Learn more" href="https://lumisinternational.com/authorized-representative/"> Authorized representative medical devices </a> </h3> <p>Your EU authorized representative for approved medical device products</p> <span class="service-link"> <a aria-label="Learn more" href="https://lumisinternational.com/authorized-representative/"> Learn more <svg aria-hidden="true"><use xlink:href="/wp-content/themes/lumis-child/svg-defs.svg#long-arrow-right"></use></svg> </a> </span> </li> <li> <h2 class="flash-dark-orange">Consulting services</h2> <figure class="intro-image"><img width="660" height="219" src="https://lumisinternational.com/wp-content/uploads/2025/02/dna-helix-with-hand.jpg" class="attachment-full size-full" alt="DNA helix with hand" decoding="async" /></figure> <p>Lumis Consulting Services provides comprehensive support for outsourcing and overseeing clinical trials, implementing quality management solutions, and addressing regulatory challenges in biopharmaceutical and with medical devices.</p> </li> <li class="consulting-service"> <figure> <a aria-label="Learn more" href="https://lumisinternational.com/pharmaceutical-and-biotechnology-regulatory-consulting-services/"> <img aria-hidden="true" src="https://lumisinternational.com/wp-content/uploads/2025/02/medicines-regulatory-consulting-simple.png" alt="" /> </a> </figure> <h3> <a aria-label="Learn more" href="https://lumisinternational.com/pharmaceutical-and-biotechnology-regulatory-consulting-services/"> Pharmaceutical & biotechnology regulatory consulting & services </a> </h3> <p>Safeguard regulatory compliance in biopharmaceutical development</p> <span class="service-link"> <a aria-label="Learn more" href="https://lumisinternational.com/pharmaceutical-and-biotechnology-regulatory-consulting-services/" target=""> Learn more <svg aria-hidden="true"><use xlink:href="/wp-content/themes/lumis-child/svg-defs.svg#long-arrow-right"></use></svg> </a> </span> </li> <li class="consulting-service"> <figure> 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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.</p> <p> <a class="primary-button" href="https://lumisinternational.com/how-authorised-representatives-support-vigilance-activities/" aria-label="A Vigilant Ally – How Authorised Representatives Support Vigilance Activities"> <span class="screen-reader-text">A Vigilant Ally – How Authorised Representatives Support Vigilance Activities</span> Read more </a> </p> </div><!-- .post-details --> </div> </div><!-- .post-container --> <hr> <div class="post-container"> <h2 class="post-title h3"><a href="https://lumisinternational.com/beyond-compliance-transform-your-authorized-representative-into-a-strategic-partner/">Beyond Compliance: Transform Your Authorized Representative into a Strategic Partner</a></h2> <div class="post-image-details"> <div class="post-image"> <a href="https://lumisinternational.com/beyond-compliance-transform-your-authorized-representative-into-a-strategic-partner/"> <img width="951" height="634" src="https://lumisinternational.com/wp-content/uploads/2025/02/authorized-rep-beyond-compliance.jpg" class="attachment-full size-full wp-post-image" alt="Map of Europe centred around southern Germany" decoding="async" /> </a> </div> <div class="post_details"> <span class="category-display"><span class="category-display-label">Topic: </span> <a href="https://lumisinternational.com/category/medical-device-authorized-representative/" alt="View all posts in Authorized representative medical devices">Authorized representative medical devices</a> </span> <p>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. 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