| Combining clinical-based evaluation with global regulatory strategy to strengthen support for international market entry
▲ (Left) Yang-Hyun Cho, Head of the Usability Test Center, Samsung Medical Center / (Right) Seungmi Lee, Partner, JNPMEDI
JNPMEDI, an AI platform-based consulting firm specializing in new drug and innovative medical device development (CEO Kwunho Jeong), announced on the 23rd that it has signed a memorandum of understanding (MOU) with Samsung Medical Center to collaborate on usability engineering support and usability evaluation for medical devices.
The agreement was signed at the Smart Healthcare Research Institute of Samsung Medical Center. Through this partnership, the two organizations aim to combine usability evaluation with global regulatory expertise to support medical device companies in strengthening product competitiveness and expanding into international markets.
Under the agreement, the two parties will collaborate in various areas, including usability evaluation and related services, preparation and knowledge sharing for global certifications such as CE and FDA, and joint planning and execution of national projects.
Samsung Medical Center will provide usability evaluation and clinical services based on real-world clinical environments, supporting companies in achieving faster and more reliable product validation.
JNPMEDI will support usability evaluation for CE and FDA approvals based on its expertise in global regulatory strategy and its digital regulatory affairs (RA) solutions. The company also plans to expand joint projects and client collaboration by leveraging its global network.
Seungmi Lee, Partner at JNPMEDI, stated, “This agreement represents a collaborative model that effectively connects clinically validated usability evaluation capabilities with global regulatory strategy. We expect that this integrated support system—from early-stage development to global market entry—will significantly accelerate our clients’ international expansion.”
Yang-Hyun Cho, Head of the Usability Evaluation Center at Samsung Medical Center, said, “Leveraging our usability evaluation capabilities based on real clinical environments, we will support companies in meeting global standards more quickly and accurately. Through our collaboration with JNPMEDI, we expect to create strong synergies across the entire medical device development and commercialization process.”
Going forward, the two organizations plan to expand the scope of collaboration in medical device usability evaluation through joint projects and continue to enhance a practical support model for global market entry.
| Combining clinical-based evaluation with global regulatory strategy to strengthen support for international market entry
JNPMEDI, an AI platform-based consulting firm specializing in new drug and innovative medical device development (CEO Kwunho Jeong), announced on the 23rd that it has signed a memorandum of understanding (MOU) with Samsung Medical Center to collaborate on usability engineering support and usability evaluation for medical devices.
The agreement was signed at the Smart Healthcare Research Institute of Samsung Medical Center. Through this partnership, the two organizations aim to combine usability evaluation with global regulatory expertise to support medical device companies in strengthening product competitiveness and expanding into international markets.
Under the agreement, the two parties will collaborate in various areas, including usability evaluation and related services, preparation and knowledge sharing for global certifications such as CE and FDA, and joint planning and execution of national projects.
Samsung Medical Center will provide usability evaluation and clinical services based on real-world clinical environments, supporting companies in achieving faster and more reliable product validation.
JNPMEDI will support usability evaluation for CE and FDA approvals based on its expertise in global regulatory strategy and its digital regulatory affairs (RA) solutions. The company also plans to expand joint projects and client collaboration by leveraging its global network.
Seungmi Lee, Partner at JNPMEDI, stated, “This agreement represents a collaborative model that effectively connects clinically validated usability evaluation capabilities with global regulatory strategy. We expect that this integrated support system—from early-stage development to global market entry—will significantly accelerate our clients’ international expansion.”
Yang-Hyun Cho, Head of the Usability Evaluation Center at Samsung Medical Center, said, “Leveraging our usability evaluation capabilities based on real clinical environments, we will support companies in meeting global standards more quickly and accurately. Through our collaboration with JNPMEDI, we expect to create strong synergies across the entire medical device development and commercialization process.”
Going forward, the two organizations plan to expand the scope of collaboration in medical device usability evaluation through joint projects and continue to enhance a practical support model for global market entry.