Representing your medical innovation.
Empowering your product development.

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

Lumis is your gateway to Europe. We empower the development of your drug or medical device with tailored strategies, analytics and solutions, ensuring reduced time-to-market with realistic budgets and the highest quality standards.

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

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The latest from Lumis Content Hub

A Vigilant Ally – How Authorised Representatives Support Vigilance Activities

Surgical instruments in an operating theatre
Topic: Authorized representative medical devices

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.

A Vigilant Ally – How Authorised Representatives Support Vigilance Activities Read more


Beyond Compliance: Transform Your Authorized Representative into a Strategic Partner

Map of Europe centred around southern Germany
Topic: Authorized representative medical devices

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.

Beyond Compliance: Transform Your Authorized Representative into a Strategic Partner Read more


Webinar: How to devise a global orphan designation strategy

How to develop a global orphan designation strategy
Topic: Pharmaceutical & biotechnology regulatory consulting & services

Developing a winning regulatory strategy for Orphan Designation across the EU, USA and APAC.

Webinar: How to devise a global orphan designation strategy Read more