Empowering Biopharma & MedTech Companies to Enter and Navigate EU, UK and Swiss Markets

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At Lumis, we provide specialized legal representation and consulting services for small to mid-sized biopharma and medical device companies conducting clinical trials worldwide.

We accelerate your drug development and clinical trials with tailored strategies, analytics and solutions, ensuring reduced time-to-market and realistic budgets while maintaining the highest quality standards.

Partnering with Lumis gives you access to over 20 years of comprehensive expertise in consulting and managing international clinical projects.

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The latest from Lumis Content Hub

Navigating the Labyrinth: The CE-Marking Challenges for AiMD and SaMD in the EU

Illustration for AiMD and SaMD, showing a computer screen, a brain, a mobile device, a syringe and other elements linking technology to medical interests
Topic: Medical device regulatory consulting & services

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 EURead more


How Small Medical Device Companies Can Successfully Go Global

A map of the world in colour with various countries marked with pins. A pin marking Brazil is in the centre.
Topic: Global representative medical devices

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.

How Small Medical Device Companies Can Successfully Go GlobalRead more


Navigating the Labyrinth: The CE-Marking Challenges for AiMD and SaMD in the EU

Illustration for AiMD and SaMD, showing a computer screen, a brain, a mobile device, a syringe and other elements linking technology to medical interests
Topic: Medical device regulatory consulting & services

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 EURead more

How Small Medical Device Companies Can Successfully Go Global

A map of the world in colour with various countries marked with pins. A pin marking Brazil is in the centre.
Topic: Global representative medical devices

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.

How Small Medical Device Companies Can Successfully Go GlobalRead more