Inspection/Storage of medical device

Over 25 years of experience as a Medical Device Manufacturer

We have more than 25 years of experience as a Medical Device Manufacturer, especially as a manufacturing facility that handles “Storage of finished products in Japan” of imported medical devices, and we have handled a wide variety of products. We receive, inspect, pack, label, and store products under appropriate management.

Receipt We inspect incoming products and prepare import records. We can flexibly accept incoming shipments at our Tokyo Head Office and Chiba Plant according to customer requests, product characteristics, and quantities.

Inspection This is one of our specialties. We have handled a large number of products, and our inspectors, who have undergone education and training under thorough control, are able to identify non-conformities according to the requirements of the products. We have a track record of identifying microscopic foreign matter down to 0.08㎟. The inspection environment is thoroughly sanitized and temperature controlled.

Regulatory labeling and packaging Products that pass the quality inspection are packaged and legally labeled according to the procedures specified in the QMS.

Storage/ Documents control Products are stored under strict hygiene control until shipment, and document control is performed in accordance with QMS ordinances. The Chiba Plant, which opened in 2022, is capable of handling large medical devices and large volumes of products.

Main flow of the delivery process

Meeting
Setting of inspection criteria

• Check the items to be inspected and set the inspection criteria.
• Set a schedule for delivery.

Receipt

• Verify quantities upon receipt to ensure that quantities are correct.
• Prepare forms.

Inspection

• Perform inspections in accordance with the inspection standards.
• Provide information on the details of defects as needed.

Aggregation and classification

• Separate conformed products from defective products and perform quantity checks.
• Prepare limit samples of products upon request.

Delivery

• Deliveries are made at the date and time requested by the customer.

Examples of products we have handled

ECG Monitors Electrocardiographic Data Recorder Electrocardiographic Electrodes Filters for syringes

Corrective devices for vertebrae Orthopedic bone cement Orthopedic cement dispensers General-purpose suction tips

Electrodes for Cardiac Pacemakers Continuous measurement electronic thermometers Cardiac Catheters Catheter-type electrodes for heart

Cooperation with MAH (Marketing Authorization Holder)

We are also licensed as a MAH (Marketing Authorization Holder) of medical device, which enables us to perform the entire process from importing medical devices to making shipping judgement for delivery to the market. We can smoothly handle customs clearance, shipping judgment, and handling of defects after product shipment.