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Clinical Trials and MDR Certification partners for rehabilitation technologies in the frame of EP Per Med Project

Summary

Closed for EoI
Profile Type
  • Research & Development Request
POD Reference
RDRRO20240212017
Term of Validity
12 February 2024 - 11 February 2025
Company's Country
  • Romania
Type of partnership
  • Research and development cooperation agreement
Targeted Countries
  • All countries
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General information

Short Summary
The aim of the innovative Romanian startup centers around leveraging Virtual Reality (VR) technology to enhance the recovery process (especially for hand rehabilitation), aiming to make it more immersive, efficient and accessible to patients worldwide.
They are looking for Clinical Trials and MDR Certification consortium partners, to develop ready for the market technologies.
Full Description
Innovative technologies will be developed during the project, aiming to improve the delivery of rehabilitation services. Moreover, an interdisciplinary approach to rehabilitation is promoted, encouraging collaboration among healthcare professionals, researchers, engineers and technologists.
The project will be submitted in the frame of EP Per Med EU Call.
The European Partnership for Personalised Medicine (EP PerMed), supported by the European Union under Horizon Europe (Grant Agreement N° 101137129), launches its first joint transnational call (JTC2024) for proposals on “Identification or Validation of Targets for Personalised Medicine Approaches (PMTargets)”.
The recognition of each patient's uniqueness, encompassing their distinct needs, preferences, and characteristics, is a fundamental principle.
Through the adoption of a personaliSed medicine framework, the aim is to customiSe rehabilitation interventions to meet the specific requirements of each patient, thereby ensuring optimal outcomes and an enhanced quality of life.
Advantages and Innovations
Innovative Application: The use of VR in medical rehabilitation represents a novel approach to addressing physical therapy needs, especially for hand rehabilitation. This technology moves beyond conventional VR applications, venturing into a specialised healthcare domain.
Complex Problem-Solving: addresses complex medical challenges, such as improving motor skills and functionality in patients with hand mobility issues, through a technologically advanced solution.
Stage of Development
  • Under development
Sustainable Development Goals
  • Goal 3: Good Health and Well-being
IPR description
The company is looking for two partners with specialised expertise:
1. Specialised in Rehabilitation: A partner with a deep understanding of rehabilitation processes, particularly in hand therapy. They are looking for innovators with a strong background in developing or implementing rehabilitation solutions that have demonstrably improved patient care and recovery outcomes.
2. Specialized in Medical Certification (MDR Regulation): A partner with extensive experience in the medical certification process within the European healthcare system. This partner should have a proven track record of navigating the regulatory landscape, ensuring that medical products meet all necessary standards and certifications for deployment in healthcare settings.

Partner Sought

Expected Role of a Partner
Their future partners will fill the roles needed for Clinical Trials and MDR Certification, emphasising the crucial role of rehab centres and clinics in their quest for support. They acknowledge the substantial resources and expertise required for these endeavors and seek collaborators who can provide essential support.
Clinical trials play a pivotal role in validating medical treatments and devices, requiring adherence to regulatory guidelines and diverse patient recruitment for reliable results. Patient feedback is vital for informing research and ensuring patient-centric healthcare innovation.

Conducting clinical trials involves various tasks, including patient recruitment, data analysis, and regulatory compliance.
Partnerships with rehab centres and clinics are essential due to their infrastructure, patient networks, and regulatory knowledge, facilitating smooth trial execution.
Obtaining Medical Device Regulation (MDR) certification is crucial for marketing devices in
the EU, demanding meticulous attention to detail and compliance with regulatory standards. Partnerships with experienced organisations can streamline the certification process, ensuring timely market entry.

Through collaborations with rehab centres, clinics, and regulatory experts, they aim to advance medical innovation. Together, they strive to develop treatments and devices that improve patient outcomes and transform healthcare delivery.

In conclusion, partnerships with rehab centres and clinics play a pivotal role in facilitating clinical trials and obtaining MDR certification. By leveraging collective expertise and resources, they aim to drive healthcare innovation forward and enhance patient care.
Type and Size of Partner
  • SME 50 - 249
  • SME 11-49
Type of partnership
  • Research and development cooperation agreement

Call details

Framework program
  • ICT for health, ageing well and inclusion
Call title and identifier
EP PerMed
Anticipated project budget
250.000 Euro / partener country
Coordinator required
No
Deadline for EoI
Deadline of the call
Web link to the call
https://www.eppermed.eu/

Dissemination

Technology keywords
  • 06001013 - Medical Technology / Biomedical Engineering
  • 09006002 - Technical Standards
  • 01004001 - Applications for Health
Market keywords
  • 02007012 - Medical/health software
  • 05007006 - Computer-aided diagnosis and therapy
  • 05003001 - Therapeutic services
Sector Groups Involved
  • Health
  • Digital
Targeted countries
  • All countries