HNN3.0

Project cooperationUpdated on 19 January 2026

Clinical Affairs & Research Support for Medical Devices (with Hospital & In-House Laboratory)

Head of Business Development and Marketing at D.med Software

Málaga, Spain

About

D.med Technologies offers end-to-end clinical affairs and research expertise to support medical device development, regulatory compliance, and clinical evidence generation. We bridge the gap between innovation and clinical validation by integrating clinical expertise, regulatory insight, and hands-on research capabilities that accelerate product readiness and market acceptance.

Our services include the preparation of Clinical Evaluation Plans and Reports (CEP/CER) according to EU MDR and MEDDEV 2.7/1 Rev.4, and the design and conduct of clinical investigations in line with MDR, MEDDEV, and ISO 14155:2020 requirements. We also carry out clinical studies and collect high-quality clinical data for device development, registration, and AI applications, leveraging real-world clinical environments.

Unique to our offering is direct access to D.med Medical, our state-of-the-art hospital in Macedonia with a dedicated clinical team and in-house laboratory. This facility enables feasibility studies, data collection across medical specialties (including internal medicine, cardiology, gastroenterology, dermatology, and nephrology), and ethically conducted clinical activities under professional oversight.

We work closely with healthcare professionals to ensure smooth transitions from preclinical evaluations to clinical validation, providing robust evidence to support regulatory submissions and health technology assessments. This integrated clinical and research ecosystem supports your project’s success at every stage of development.

Ideal cooperation partners:

  • Horizon Europe / Cluster Health research consortia

  • Medical device innovators seeking clinical validation and evidence

  • SMEs and startups preparing clinical data for regulatory submissions

  • Partners aiming to harness real-world data and advanced clinical studies

Topic

  • DESTINATION 2: HORIZON-HLTH-2026-01-ENVHLTH-04: Towards climate resilient, prepared and carbon neutral populations and healthcare systems
  • DESTINATION 3: HORIZON-HLTH-2026-01-DISEASE-02: Innovative interventions to prevent the harmful effects of using digital technologies on the mental health of children and young adults
  • DESTINATION 3: HORIZON-HLTH-2026-01-DISEASE-03: Advancing research on the prevention, diagnosis, and management of post-infection long-term conditions
  • DESTINATION 3: HORIZON-HLTH-2026-01-DISEASE-09: Multisectoral approach to tackle chronic non-communicable diseases: implementation research maximising collaboration and coordination with sectors and in settings beyond the healthcare system (GACD)
  • DESTINATION 3: HORIZON-HLTH-2026-01-DISEASE-11: Understanding of sex and/or gender-specific mechanisms of cardiovascular diseases: determinants, risk factors and pathways
  • DESTINATION 3: HORIZON-HLTH-2026-01-DISEASE-15: Scaling up innovation in cardiovascular health
  • DESTINATION 4: HORIZON-HLTH-2026-01-CARE-01: Public procurement of innovative solutions for improving citizens' access to healthcare through integrated or personalised approaches
  • DESTINATION 4: HORIZON-HLTH-2026-01-CARE-03: Identifying and addressing low-value care in health and care systems
  • DESTINATION 5: HORIZON-HLTH-2026-01-TOOL-03: Integrating New Approach Methodologies (NAMs) to advance biomedical research and regulatory testing
  • DESTINATION 5: HORIZON-HLTH-2026-01-TOOL-05: Pilot actions for follow-on funding: Leveraging EU-funded collaborative research in regenerative medicine
  • DESTINATION 5: HORIZON-HLTH-2026-01-TOOL-06: Support to European Research Area (ERA) action on accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicinal products and medical devices
  • DESTINATION 6: HORIZON-HLTH-2026-01-IND-03: Regulatory science to support translational development of patient-centred health technologies

Type

  • Partner seeks Consortium/Coordinator

Organisation

D.med Software

Company (SME)

Málaga, Spain

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