JNPMedi, an AI platform-based consulting company specializing in new drug and innovative medical device development, announced on June 4 that it has obtained ISO 13485 certification, the international standard for medical device quality management systems (QMS).
ISO 13485 is a globally recognized standard that evaluates the suitability of quality management systems across the entire medical device lifecycle, including design, development, manufacturing, installation, and servicing. It is widely regarded as a benchmark for ensuring quality and safety in the medical device industry.
The certification was awarded following an audit by BSI, a globally recognized standards and certification organization. The certified scope covers clinical research and regulatory consulting services for medical devices.
The certification is particularly significant because JNPMedi is not a medical device manufacturer but a company specializing in clinical development and regulatory affairs. The company established a quality management framework for its medical device clinical trial and regulatory consulting services and successfully validated the system against international standards.
To achieve certification, JNPMedi developed standard operating procedures (SOPs) aligned with medical device quality management requirements, enhanced its project execution and document management systems, and implemented processes to ensure traceability and objectivity across its operations.
Lee Seung-mi, Executive Vice President of JNPMedi, said, “ISO 13485 certification demonstrates that we have established and embedded a medical device-specific quality management system throughout the organization. We will continue strengthening our expertise to help medical device companies advance their businesses more efficiently.”
Meanwhile, JNPMedi has continued its growth trajectory. The company previously reported that its revenue increased by 250% year over year in 2025. During the year, it added more than 100 new clients across the pharmaceutical, biotechnology, medical device, and digital health sectors and secured more than 20 global clinical research projects.