Nemko Korea has entered into an MoU with Seum Partners Co. Ltd.in order to strengthen its services in the medical device sector by establishing a framework for mutual cooperation.
Seum Partners is a medical device consulting firm that supports clients’ market entry by leveraging deep expertise and hands on experience in both global and domestic regulatory requirements. Its key services include consulting for medical device regulatory approvals, typically for supporting the establishment and operation of ISO13485 based Quality Management Systems (QMS)
In addition, the company provides a wide range of services such as medical device software verification, cyber-security related technical- and regulatory documentation consultancy, as well as clinical strategy development and execution support.
With the medical device market growing rapidly, the need for specialized consulting services has been increasing. Manufacturers in this field require professional support in areas such as regulatory approval, quality systems and technical documentation.
A Memorandum of Understanding (MoU) has also been signed between Nemko Korea and MediGuide Co. Ltd. to strengthen its professional capabilities in the medical device sector and ensure having an advanced customer support framework. This marks another significant step in Nemko Korea’s aim to expand service offerings and provide integrated solutions to its clients.
MediGuide is a consulting firm specializing in domestic and international medical device regulatory approvals and quality management system (QMS) certifications. As the Korean partner of the global medical device consulting group ARQon Group, MediGuide provides certification services for more than 30 countries.
Its strong technical expertise and global reach complement Nemko Korea’s testing & certification services. The collaboration will include mutual exchange of technical knowledge and information, establishment of cooperative systems for testing & certification and technical standards, and also joint organization and participation in training programs and seminars.
The parties have agreed to pursue continuous collaboration and joint growth strategies across the medical device
industry, contributing to strengthen the global competitiveness of domestic clients.
For further information, please contact Sangyeop.Lee@Nemko.com