Lumis blog posts

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.

Integrating Service Provider Management and Risk‑Based Quality Systems under ICH E6(R3) Read more

This year Lumis attended 14 conferences – ensuring we are up to date with the latest industry trends and news. Our experts presented at conferences, sharing their experience, insights, and demonstrating their thought leadership.

2025 Conference Insights: What industry trends may impact your business? Read more

2025 was a year of very tangible progress for Lumis. While medical technology and biotechnology companies continued to navigate MDR, IVDR and complex EU market entry, our role became increasingly clear. We were asked to do more than explain regulations. We were asked to translate uncertainty into concrete decisions.

KPI Snapshot & Year in Review Read more

If we took a team picture at the beginning of 2025 and compared it with today, the difference would not only be in the number of faces. It would also be in how clearly each person knows what they contribute and how those roles connect across Lumis. This piece is a small snapshot of that change in people, not in org charts.

Big Faces of Lumis and Team Moves Read more

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

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 Global Read more

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

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.

Why You Need a Legal Representative for Clinical Trials in Europe Read more

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

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