Strategic partnership between Normec and KOTHEA strengthens European access for Korean digital health companies
Bologna, Italy – May 2026 – Normec announces the signing of a Memorandum of Understanding (MoU) between its Italian medical device certification entity Ente Certificazione Macchine (ECM) and the Korea Total Healthcare Ecosystem Association (KOTHEA). The agreement marks the start of a strategic collaboration aimed at supporting Korean digital healthcare companies in accessing the European medical device market.
The official signing ceremony took place at ECM’s headquarters in Valsamoggia (Bologna), bringing together institutional representatives, healthcare industry leaders and international delegations from both Italy and South Korea.
Supporting innovation in digital healthcare
The partnership focuses on supporting Korean companies active in digital health technologies, particularly Software as a Medical Device (SaMD) and AI-based diagnostic solutions, in obtaining CE certification under the European Medical Device Regulation (MDR).
Through this collaboration, Normec and KOTHEA aim to facilitate market access while strengthening international cooperation in healthcare innovation and regulatory excellence.
The agreement includes four main areas of cooperation:
Continuous exchange of information regarding European regulatory requirements;
Certification support to streamline communication and reduce uncertainties for manufacturers;
Capacity building through seminars, workshops and technical training initiatives;
Industrial networking to stimulate collaboration and business development opportunities between Korean manufacturers and the broader Normec and ECM ecosystem.
Combining international reach with technical expertise
Under the agreement, KOTHEA will identify and support leading Korean digital health companies seeking entry into Europe. ECM, as part of Normec’s Healthcare & Life Sciences activities, will provide technical and regulatory expertise to ensure efficient and reliable conformity assessment processes.
During the ceremony, several speakers highlighted the growing importance of international collaboration in digital healthcare and medical technology.
Renato Biffi, Healthcare Italy Manager at Normec Group, emphasized the strategic relevance of the partnership for the wider Normec organization:
“This collaboration aligns perfectly with oNrmec’s vision of strengthening technical excellence and supporting sustainable long-term growth within Healthcare & Life Sciences. Together with ECM and KOTHEA, we are building stronger international bridges for innovation and compliance.”
Luca Bedonni, CEO of ECM, described the agreement as an important milestone for the entire Life Sciences ecosystem. He underlined the importance of strengthening transnational dialogue between Europe and South Korea, laying a solid foundation for supporting technological innovation and access to international markets.
Representatives from the Republic of Korea, the Emilia-Romagna Region and local authorities also stressed the importance of the agreement in fostering internationalization, innovation and trust in healthcare systems.
Creating opportunities for future collaboration
The event concluded with a networking session between companies, institutions and sector professionals, laying the foundation for future technological and commercial developments in digital healthcare.
Through this partnership, Normec further strengthens its position as an international partner for testing, inspection, certification and regulatory support in the rapidly evolving global healthcare market.
Event attendees included:
Luca Bedonni – CEO, ECM
Renato Biffi – Healthcare Italy Manager, Normec Group
Heekyung Jung – Secretary General, KOTHEA
CHOI Taeho – Consul General of the Republic of Korea in Milan
Maurizio Fabbri – President of the Regional Assembly of Emilia-Romagna
Gianluca Baldoni – Emilia-Romagna Region
Paolo Crescimbeni – Metropolitan Managing Director for Productive Activities
Milena Zanna – Mayor of Valsamoggia
Federica Govoni – Deputy Mayor of Valsamoggia
Kijoon Shim – President of KOTHEA
Seongjun Lim – General Manager Global Expansion Projects, KOTHEA
About Normec
Normec is a leading international provider of Testing, Inspection, Certification, and Compliance (TICC) services, helping organizations safeguard quality, safety, health, and sustainability. Headquartered in the Netherlands, Normec operates across Europe and the United States, with activities spanning four core divisions: Food, Safety, Sustainability, and Healthcare.
With more than 6,500 experts working in a broad network of accredited laboratories and specialist centers, Normec delivers independent, science-based solutions that support clients in meeting regulatory requirements, protecting consumers, and accelerating sustainable progress. By combining technical expertise with innovation and a strong customer focus, Normec enables organizations to anticipate future challenges with confidence.
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