ROHEALTH – The Health and Bioeconomy Cluster NGO

ROHEALTH – The Health and Bioeconomy Cluster is a Romanian cluster dedicated to advancing innovation, collaboration and sustainable development in health and bioeconomy, with a strong focus on medical devices, digital health and the translation of innovative health technologies from research to clinical practice and the market.

With over 120 members, ROHEALTH brings together companies and SMEs, medical device developers and manufacturers, universities, research institutes, hospitals, healthcare professionals, NGOs and other key stakeholders. Its expertise is structured across nine specialised working groups, enabling members to develop joint initiatives and address challenges across the health and bioeconomy sectors.

A particular area of expertise is the medical devices and health technologies ecosystem. ROHEALTH supports innovators throughout the development pathway – from research and technology transfer to clinical and technical validation, regulatory strategy, market access and adoption. Through its members and European projects, the cluster has developed significant experience related to MDR and IVDR implementation, regulatory capacity building, notified bodies, digital and AI-enabled medical technologies, and the challenges faced by SMEs in bringing innovative medical devices to the European market.

ROHEALTH initiates and coordinates strategic national and European projects, connecting researchers, healthcare professionals, industry, regulators and entrepreneurs. The cluster supports the internationalisation of its members through European consortia, economic missions and international collaboration platforms, helping SMEs access new markets, expertise and partnerships.

A key priority is strengthening the links between academia, healthcare, industry and the regulatory ecosystem, facilitating technology transfer, product development and validation, clinical uptake and market readiness. Workshops, matchmaking activities, training programmes and living lab initiatives provide practical environments in which innovative solutions can be developed, tested and connected with potential users and partners.

ROHEALTH is also actively involved in public policy and strategic initiatives, contributing the perspective of the health innovation and medical technology ecosystem to discussions on regulation, innovation, competitiveness, sustainability and access to healthcare technologies. Through conferences, forums, debates, specialised training programmes and international partnerships, ROHEALTH fosters a collaborative community in which knowledge, expertise and good practices are continuously exchanged, reinforcing its role as a bridge between innovation, regulation, healthcare and the market at both national and European level.

ROHEALTH is the only Romanian cluster in the Health and Medical Sciences field holding the ESCA Gold Label certification, recognising excellence in cluster management.