SciTransfer
Organization

OBELIS SA

Belgian SME providing EU regulatory affairs and market access expertise for diagnostic devices, biosensors, and health technologies.

Innovation consultancyhealthBESMENo active H2020 projects
H2020 projects
3
As coordinator
0
Total EC funding
€867K
Unique partners
27
What they do

Their core work

Obelis is a Brussels-based regulatory affairs consultancy specializing in EU market access for medical devices, diagnostics, and health technologies. In H2020 projects, they contribute regulatory and compliance expertise to consortia developing biosensors (GLAM), cancer detection nanotechnologies (HypoSens), and COVID-19 diagnostic platforms (INNO4COV-19). Their role bridges the gap between laboratory innovation and the regulatory pathway needed to bring health technologies to the European market. As an SME, they offer specialized knowledge that research-heavy consortia typically lack in-house.

Core expertise

What they specialise in

Regulatory affairs for medical devices and diagnosticsprimary
3 projects

All three H2020 projects (GLAM, HypoSens, INNO4COV-19) involve diagnostic or biosensor technologies requiring EU regulatory navigation.

Biosensor and diagnostic device complianceprimary
2 projects

GLAM (laser multiplexed biosensor) and HypoSens (nano-confined photonic detection system) both develop novel diagnostic devices needing market authorization.

COVID-19 and pandemic response innovationemerging
1 project

INNO4COV-19 project focused on boosting innovation for COVID-19 diagnostics, prevention, and surveillance.

EU market access strategy for health technologiessecondary
3 projects

Consistent participation across health-focused consortia suggests deep understanding of the CE marking and IVDR pathways.

Evolution & trajectory

How they've shifted over time

Early focus
Diagnostic device regulation
Recent focus
Pandemic diagnostics and innovation platforms

Obelis entered H2020 through advanced diagnostic hardware projects — GLAM (laser biosensors, 2015) and HypoSens (nano-photonic breast cancer detection, 2016) — both focused on bringing physical sensing devices toward market readiness. By 2020, their focus shifted toward platform-based and rapid-response innovation with INNO4COV-19, which dealt with open innovation platforms and key enabling technologies for pandemic diagnostics. This suggests a broadening from device-specific regulatory support toward ecosystem-level innovation facilitation.

Obelis is moving from supporting individual device projects toward broader roles in health innovation ecosystems and rapid-response diagnostic platforms.

Collaboration profile

How they like to work

Role: specialist_contributorReach: European13 countries collaborated

Obelis operates exclusively as a participant, never leading consortia — consistent with their role as a specialist service provider that research teams bring in for regulatory expertise. With 27 unique partners across just 3 projects, they work in medium-to-large consortia (averaging 9+ partners per project), indicating comfort in complex multi-partner environments. Their non-repeating partner base suggests they are recruited for their specific expertise rather than relying on established consortium cliques.

Obelis has collaborated with 27 distinct partners across 13 countries in just 3 projects, reflecting broad European reach. Their Brussels base positions them at the heart of EU regulatory and institutional networks.

Why partner with them

What sets them apart

Obelis fills a critical niche that most research consortia struggle with: the regulatory and market access pathway for health technologies in the EU. While many partners bring scientific or engineering capability, Obelis brings the knowledge of how to get a diagnostic device from prototype to CE-marked product. For consortium builders, adding Obelis signals to evaluators that the project has a credible route to market — not just a research plan.

Notable projects

Highlights from their portfolio

  • GLAM
    Largest EC contribution to Obelis (EUR 409,800) for a laser multiplexed biosensor — their highest-funded and earliest H2020 engagement.
  • INNO4COV-19
    Rapid-response COVID-19 project (2020-2022) demonstrating Obelis's ability to pivot quickly into pandemic diagnostics and open innovation platforms.
  • HypoSens
    Nano-confined photonic system for breast cancer lymph node detection — combines advanced nanotechnology with a clear clinical diagnostic application.
Cross-sector capabilities
Medical device regulatory complianceIn-vitro diagnostics (IVD) market accessDigital health platform regulationKey enabling technologies commercialization
Analysis note: Profile based on only 3 projects with limited keyword data for the earlier two (GLAM, HypoSens). The regulatory affairs role is inferred from the combination of project types, SME status, participant-only role, and known company profile — but CORDIS data alone does not explicitly confirm their specific contribution to each consortium. Confidence would increase with access to deliverable-level data or project website descriptions.