| Dedicated Unit to Advance Korea’s Medical Device Industry and Global Competitiveness
| Comprehensive Solutions: Regulatory Support, Digital Health Validation, Global Expansion
| Empowering Companies with Training and Expert Consulting in Clinical & Commercialization
| Boosting Industry Competitiveness and Driving Sustainable Growth
<JNPMEDI Senior Managing Director SeungMi Lee>
JNPMEDI is driving the advancement of Korea’s medical device industry and supporting companies in achieving global innovation.
On February 25, JNPMEDI, a clinical trial consulting and platform company, announced the launch of its specialized unit, the MedTech & Globalization Offering Group, dedicated to providing comprehensive, end-to-end support for the medical device industry. This new unit is designed to maximize on-demand service capabilities across all stages of the medical device business, offering innovative solutions in key areas such as domestic and international regulatory approvals, digital healthcare validation, and global market expansion strategies.
From the early stages of product development to GMP/ISO 13485 certification and new medical technology assessment for insurance coverage and commercialization, the unit provides systematic support throughout the entire process. Leveraging extensive experience with major regulatory bodies—including the U.S. FDA, European CE, Japan’s PMDA, and China’s NMPA—the unit delivers strategic guidance for successful market entry, even within complex regulatory landscapes.
JNPMEDI is developing a range of strategic plans to facilitate swift and accurate decision-making for regulatory approvals and clinical trials. In Korea, the company is strengthening its approach to successful clinical trials and regulatory compliance by adhering to the Digital Medical Product Act and leveraging real-world evidence (RWE) and real-world data (RWD). Additionally, it is establishing operational guidelines that incorporate the latest global standards, including ICH E6(R3), ISO 14155, and ISO 20916, while implementing a risk-based monitoring (RBM) system for clinical trials to enhance efficiency. Furthermore, JNPMEDI is formulating regulatory strategies aligned with the stricter European medical device regulations (MDR/IVDR) to improve clinical evidence and conduct comprehensive risk assessments.
The company also provides strategic support for global market expansion and commercialization. By tailoring clinical trial designs to each client’s business investment and commercialization strategies, JNPMEDI ensures seamless support across the entire RDC (Research, Development, and Commercialization) process, from product launch to post-market management. The company actively collaborates on various government projects and offers customized consulting and training programs to foster sustainable growth for medical device companies.
Through these initiatives, JNPMEDI aims to become a key partner for medical device companies, enabling them to build a stable, long-term presence in the global market rather than focusing solely on short-term results. The company is establishing a structured approach to business strategy development that supports sustained global expansion.
SeungMi Lee, Senior Managing Director of JNPMEDI, stated, “In today’s rapidly evolving technological landscape and complex regulatory environment, Korean medical device companies seek more than just success in clinical trials and regulatory approvals. They need a strategic partner who can guide them through the early stages of business model development with a comprehensive approach.” She added, “This newly launched unit will serve as a core partner, providing end-to-end support and systematic strategic planning to help companies achieve not only growth but also successful entry into the global market.”
She further emphasized, “JNPMEDI remains committed to driving the sustainable growth of our clients while accelerating the digital transformation of the medical device industry. We will continue to strengthen Korea’s market competitiveness and enhance its position in the global industry.”
| Dedicated Unit to Advance Korea’s Medical Device Industry and Global Competitiveness
| Comprehensive Solutions: Regulatory Support, Digital Health Validation, Global Expansion
| Empowering Companies with Training and Expert Consulting in Clinical & Commercialization
| Boosting Industry Competitiveness and Driving Sustainable Growth
<JNPMEDI Senior Managing Director SeungMi Lee>
JNPMEDI is driving the advancement of Korea’s medical device industry and supporting companies in achieving global innovation.
On February 25, JNPMEDI, a clinical trial consulting and platform company, announced the launch of its specialized unit, the MedTech & Globalization Offering Group, dedicated to providing comprehensive, end-to-end support for the medical device industry. This new unit is designed to maximize on-demand service capabilities across all stages of the medical device business, offering innovative solutions in key areas such as domestic and international regulatory approvals, digital healthcare validation, and global market expansion strategies.
From the early stages of product development to GMP/ISO 13485 certification and new medical technology assessment for insurance coverage and commercialization, the unit provides systematic support throughout the entire process. Leveraging extensive experience with major regulatory bodies—including the U.S. FDA, European CE, Japan’s PMDA, and China’s NMPA—the unit delivers strategic guidance for successful market entry, even within complex regulatory landscapes.
JNPMEDI is developing a range of strategic plans to facilitate swift and accurate decision-making for regulatory approvals and clinical trials. In Korea, the company is strengthening its approach to successful clinical trials and regulatory compliance by adhering to the Digital Medical Product Act and leveraging real-world evidence (RWE) and real-world data (RWD). Additionally, it is establishing operational guidelines that incorporate the latest global standards, including ICH E6(R3), ISO 14155, and ISO 20916, while implementing a risk-based monitoring (RBM) system for clinical trials to enhance efficiency. Furthermore, JNPMEDI is formulating regulatory strategies aligned with the stricter European medical device regulations (MDR/IVDR) to improve clinical evidence and conduct comprehensive risk assessments.
The company also provides strategic support for global market expansion and commercialization. By tailoring clinical trial designs to each client’s business investment and commercialization strategies, JNPMEDI ensures seamless support across the entire RDC (Research, Development, and Commercialization) process, from product launch to post-market management. The company actively collaborates on various government projects and offers customized consulting and training programs to foster sustainable growth for medical device companies.
Through these initiatives, JNPMEDI aims to become a key partner for medical device companies, enabling them to build a stable, long-term presence in the global market rather than focusing solely on short-term results. The company is establishing a structured approach to business strategy development that supports sustained global expansion.
SeungMi Lee, Senior Managing Director of JNPMEDI, stated, “In today’s rapidly evolving technological landscape and complex regulatory environment, Korean medical device companies seek more than just success in clinical trials and regulatory approvals. They need a strategic partner who can guide them through the early stages of business model development with a comprehensive approach.” She added, “This newly launched unit will serve as a core partner, providing end-to-end support and systematic strategic planning to help companies achieve not only growth but also successful entry into the global market.”
She further emphasized, “JNPMEDI remains committed to driving the sustainable growth of our clients while accelerating the digital transformation of the medical device industry. We will continue to strengthen Korea’s market competitiveness and enhance its position in the global industry.”