Regulatory Science to Support Translational Development of Patient-Centred Health Technologies

We are a specialized regulatory science department within a leading research organization. Our team provides expert guidance on the entire translational pathway for health technologies, with a specific focus on integrating patient perspectives into the regulatory strategy. We help bridge the gap between innovation and market authorization.

Our Role in the Consortium: We seek to join as the Regulatory Science and Patient Engagement Partner. Our key activities would include:

• Developing and implementing a comprehensive regulatory strategy aligned with MDR/IVDR and international standards.

• Designing and executing qualification/validation plans for novel digital endpoints and patient-reported outcome (PRO) measures.

• Facilitating early dialogue with regulatory bodies (e.g., EMA, Notified Bodies).

• Integrating patient feedback into the design validation and clinical development strategy to ensure technologies are truly patient-centric and meet real-world needs.

Type of Partner Sought: We are looking to join consortia that are:

• Technology Developers: SMEs, universities, or research institutes developing novel Digital Health Technologies (DHTs), medical devices, or in-vitro diagnostics.

• Clinical Partners: Hospitals and clinical research organizations planning clinical validation studies.

• Patient Advocacy Groups: Organizations that can facilitate meaningful patient involvement throughout the development lifecycle.

We aim to support proposals under relevant Horizon Europe calls that focus on the translation and validation of new health technologies.