I-PEX Enters Medical Device Manufacturing with ISO 13645-Certified Respiratory Device Production—Manufacturing Partner for Air Water Medical, from Design to Storage

I-PEX Inc. (Headquarters: Shimogyo-ku, Kyoto; Representative Director and President: Reiji Konishi; hereinafter "I-PEX") announces that it acquired ISO 13485 certification on August 18, 2026, establishing a production and quality management system that conforms to the international quality standards required for medical device manufacturing.

In addition, for a respiratory therapy device (Class III medical device) for which Air Water Medical Inc. obtained marketing approval, I-PEX has participated as a manufacturing partner responsible for design, principal assembly, and final storage, and began mass production in June 2026.

Based on its precision processing technology, mass production technology, and automation technology, I-PEX will strengthen its manufacturing support in the medical and healthcare field. As an "Innovative Product development & Engineering solutions eXpert," it will contribute to creating an environment that supports patients' treatment continuation through the stable supply and quality assurance of medical devices.

Background

In the medical and healthcare field, against a backdrop of an aging population and diversifying medical needs, there is growing demand for product development that responds to the challenges faced by patients and medical settings. At the same time, because medical devices require high quality and safety, partners who can consistently drive everything from product planning and development to mass production are becoming increasingly important.

Leveraging the precision processing technology, mass production technology, and automation technology it has cultivated over many years, I-PEX is advancing its efforts as an "Innovative Product development & Engineering solutions eXpert" that discovers challenges together with customers and supports commercialization and mass production.

For this respiratory therapy device, I-PEX has established a mass production system responsible for design, assembly, and final storage.

Technologies Supporting Manufacturing

In its mass production processes, I-PEX utilizes the following technologies:

• High-density mounting and precision assembly technologies compatible with miniaturized devices
• Quality control and inspection processes required for medical devices
• Mass production automation technologies that realize a stable supply

In addition to these technologies, by building a system that consistently supports everything from design to mass production and quality control, I-PEX realizes high-quality and stable manufacturing in the medical device field.

Future Outlook

I-PEX will strengthen its quality framework in medical device manufacturing and advance its mass production technologies, while promoting efforts to co-create with customers everything from discovering challenges to commercialization and mass production. As an "Innovative Product development & Engineering solutions eXpert," it will support the realization of new products and services in the medical and healthcare field and contribute to solving the challenges faced by medical settings and patients.

About I-PEX Inc.

I-PEX stands for “Innovative Product development & Engineering solutions eXpert” providing value in the form of inspiration and astonishment in the global marketplace. The company was founded in 1963 as Dai-ichi Seiko, a precision mold manufacturer, and has since produced numerous world-firsts and unique products and solutions. I-PEX currently operates in five business fields: Connectors, Contract Manufacturing (Automotive Components & Electronics Components), Molds & Equipment, MEMS Foundry, Energy Solutions. By delivering the sharpest tip to the world, we will contribute to exciting value-creation in the digitalized society by working globally with every client who open up the new era.