JNPMEDI sets up unit to support medical device industry < Life science < Article

JNPMEDI said Tuesday that it has established a specialized organization, the MedTech & Globalization Offering Group, to provide full-cycle support for the medical device industry.

JNPMEDI Partner and Executive Director Lee Seung-mi

According to the company specializing in life science R&D and commercialization, the organization will maximize its on-demand service capabilities for all stages of the medical device business to provide various innovative solutions, including domestic and international licensing support, digital healthcare demonstration assistance, and global market entry strategies.

The dedicated organization will systematically support the entire process from the early stages of product development to meeting mandatory requirements such as GMP/ISO13485 certification to insurance coverage and sales through new medical technology evaluation.

The newly launched unit has extensive experience in the certification process of major regulatory authorities, such as the U.S. Food and Drug Administration (FDA), European Commission (CE), Japan’s Pharmaceutical and Medical Devices Agency (PMDA), and China’s National Medical Products Administration (NMPA), providing effective market entry strategies even in complex regulatory environments.

JN MEDI has established a rapid and accurate decision-making system for product licensing and clinical trials.

In Korea, the company supports successful clinical trials and licensure through compliance with the Digital Medical Products Act and utilizing real-world evidence (RWE/RWD) data. It will also establish business guidelines and clinical trial risk-based monitoring (RBM) systems that reflect the latest global regulations, such as ICH E6(R3), ISO 14155, and ISO 20916. In addition, the company will develop clinical evidence improvement and comprehensive risk assessment strategies in line with enhanced European medical device regulations (MDR/IVDR).

JNPMEDI will also provide strategic support for global market access.

It proposes clinical trials in line with each company’s investment and commercialization strategy and provides comprehensive support for all stages of research, development, and commercialization (RDC), including product commercialization and follow-up. The company also promotes sustainable growth through government projects, customized consulting, and training programs.

As a key partner for medical device companies, JNPMEDI plans to go beyond short-term results and build a long-term business strategy system to establish a stable position in the global market.

“In a rapidly changing technological innovation and complex regulatory environment, Korea’s medical device companies need strategic partners to realize their business models beyond simple clinical trial and approval success,” JNPMEDI Partner and Executive Director Lee Seung-mi said. “This dedicated organization will be a key partner in leading corporate growth and global market expansion through full-cycle support and systematic strategy establishment.”

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