Publication of FAQs for Medical Device ODM/OEM | Consistent Contract Manufacturing for ISO 13485

We provide contract manufacturing services for medical devices in accordance with ISO 13485-compliant processes.

We provide everything from parts procurement, manufacturing, inspection, to shipping of medical devices in a development process compliant with ISO13485, tailored to our customers' needs. Additionally, we own a factory with a clean room, allowing us to accommodate a wide range of services from prototype production to mass production of medical devices (with over 7,000 units of contract development products successfully mass-produced). With thorough management compliant with ISO13485, we offer contract manufacturing (OEM) of medical devices (ME equipment), as well as contract development and mass production of next-generation devices (such as model changes). If you have any concerns or requests regarding medical devices or healthcare-related equipment, please feel free to contact us. For more details, please feel free to convey your requests through our website. Website contact information: https://www.johnan.com/healthcare/health-contact/

• Contract manufacturing
• Other contract manufacturing
• ODM

Based on the ISO 13485 standard, we have a track record of producing 6,000 units of medical devices.

In this factory, we handle everything from parts procurement, manufacturing, inspection, packaging, to shipping all in-house. We have a clean room and can respond flexibly to customer requests. Please feel free to contact us. For more details, please visit our company website. The website for "Contract Manufacturing of Medical Devices and Healthcare Equipment (OEM)" is here: https://www.johnan.com/healthcare/manufacturing/

• Mechanical Design

We provide a consistent service from product development to mass production.

Our company specializes in medical cleaning devices, wearable devices, and IVD testing equipment (in vitro diagnostics), providing services such as new product development support and contract development (ODM) and manufacturing (OEM) of next-generation devices. We have obtained ISO 13485 certification and have established a safe and consistent quality management system that covers everything from product development of medical devices to material procurement and manufacturing. For more details, please visit our website. Medical Devices and Healthcare Equipment ODM/OEM https://www.johnan.com/healthcare/

• Contract manufacturing

Fukuda Co., Ltd. has been pursuing leak detection for 60 years and is committed to advancing the future of leak testing. 【 Supporting Various Leak Tests: Air Leak Test / Gas Leak Test (Hydrogen Gas, Helium Gas) 】 We develop, manufacture, and sell leak testing equipment to inspect airtightness and sealing properties. We will propose the appropriate testers and devices for each inspection target. 【 Target Industries and Examples of Inspection Targets 】 - Automotive Industry: Engines, FC components, valves and piping, various parts - Electronic Components Industry: Smartphones, keyless switches, various small sensors - Pharmaceuticals / Food / Cosmetics Industry: Bottle containers, syringes, vials, eye drop containers, pillow packaging, PTP packaging We will propose the most suitable leak testers for each industry. 【 ISO Certification 】JIS Q 9001:2015 (ISO 9001:2015)

In civil engineering sites, there are many instances where sheet boards are used for temporary roads, access roads, heavy machinery work yards, material storage areas, and pedestrian pathways. Traditional steel plates are heavy, which can require large cranes or heavy machinery for installation and removal, increasing the workload depending on site conditions. Hyper CLT sheet boards are civil engineering materials made from wooden CLT for civil use. The 5×10 board weighs about 230 kg, and the 5×20 board weighs about 460 kg, making them lightweight and easy to handle even with small machinery, which allows for easier installation without the need for large cranes. They also contribute to reducing the burden of transportation, installation, and removal, as well as improving maneuverability on site. Recommended as a registered technology by the Ministry of Land, Infrastructure, Transport and Tourism under NETIS "TH-250021-A," it is suitable for companies considering civil engineering, civil use, and civil CLT. This material is easy to use for creative proposals in public works, such as alternatives to steel plates, common temporary structures, temporary roads, and curing for material storage areas.

Fukuda's new flagship model. - Masterless type (FLA-0200 series) - General type (FLA-0201 series) Two models of air leak testers. With the mastering correction function, high-precision measurements can be achieved in a short time. Please take a look at the catalog.

Fukuda Co., Ltd., which develops, manufactures, and sells leak testing equipment to inspect airtightness and sealing performance, provides a technical document that clearly explains the methods and theories of airtight testing, titled "Technical Manual." We are offering it as a PDF file. Please take this opportunity to download and view it!

What is an Air Leak Tester? An "Air Leak Tester" is a device that pressurizes the inside (or outside) of a sealed workpiece with air and determines the presence of leaks based on pressure changes. When a master with no leaks and a workpiece with leaks are pressurized, the pressure on the workpiece side decreases, creating a pressure difference between the two. By measuring this pressure difference, the presence of leaks can be determined. Generally, differential pressure air leak testing is widely used, but Fukuda also offers products that utilize direct pressure leak testing and flow meters according to the leak rate, in addition to differential pressure leak testers. Since the air leak tester uses air as the measurement medium, it incurs no running costs and is environmentally friendly.