Medmain Acquires ISO13485 Certification, an International Standard for Medical Device Quality Management Systems
Medmain Inc., a Japanese medtech startup that offers PidPort, an AI-powered cloud system to assist in digital pathology, is pleased to announce that it has acquired ISO 13485 certification, the international standard for quality management systems in medical devices.
ISO 13485 is recognized as a standard for quality management practices in international medical device regulations. It is designed for organizations that can manage the design, development, and delivery of medical devices to customers at a high level of quality. ISO 13485 certification indicates that the company has developed medical devices that comply with the global standard for quality management systems in medical devices.
■Background of ISO13485 Certification
Medmain Inc. with a corporate mission “to create a world where medical services can be accessed with technology anywhere, anytime,” develops and provides PidPort, an AI-powered cloud system for digital pathology support, as a trusted partner to healthcare professionals worldwide.
While the number of pathological diagnosis and examinations has increased significantly in line with the global increase in the number of cancer diagnosis, there is a chronic shortage of manpower, resulting in an overwhelming workload for medical institutions.
In order to develop and provide PidPort to support medical institutions, maintaining the quality of service is essential for the digitization of pathological diagnosis and the provision of pathology AI.
We have recently obtained ISO 13485 certification, an international standard for quality management systems in medical devices, and this certification confirms that the design, development, and provision of our medical devices comply with international quality standards, as recognized by an independent third-party organization.
We will continue to focus on international market-oriented product development and strive to create and deliver high-quality, highly reliable products and services.
■Overview of ISO13485 Certification
Certification Standards：ISO13485：2016
Registration Number：50301629 MP2016
Certification Scope：The design of software for pathology diagnostic support
First Registration Date：January 27, 2025
Certification Body：DQS Japan Inc.