Cavite - Arkray Industry West Inc,

ARKRAY Industry West, Inc.

ARKRAY Industry West, Inc. is a leading manufacturer of top-quality medical devices such as blood glucose meters and other in-vitro medical devices. We take pride in our commitment to producing products that are fully compliant with ISO 13485, ensuring the safety and accuracy of our devices.

Our team of experts has years of experience in the industry and utilizes cutting edge technology in producing our products. ARKRAY offers solutions for electronic manufacturing services requirements from turnaround prototyping to high volume production.

With 26 years of experience using high-density mounting machines, we’ve earned a reputation as a trusted leader in producing top-quality electronic circuit boards. Since being acquired by ARKRAY Group in July 2017, we continue to provide the same expertise with the added benefit of partnering with a leading medical device manufacturer.

OUR EDGE

Arkray SMT Process

Strategic Location

Facility is located at Cavite Economic Zone in Rosario Cavite. 30 km South of Manila with a 42 mins travel distance to NAIA

Export destination

Japan, China, Republic, Korea, Other Asian countries, Europe, Russia, United States, Middle East and North Africa, Other regions

Main customers

Supermarkets and EC (E-Commerce)
B to C (Business to Consumer)

PRODUCTS OF THE CAVITE FACILITY

Printed Circuit Board Assembly

Experience the ultimate in electronic device reliability and performance with our state-of-the-art surface mounting process. Our fully enabled components can be expertly attached to single boards, double-layered boards, multi-layered boards, and even Thick Copper Circuit Boards. Trust us to deliver exceptional quality and precision in every board we create.

Flexible Circuit Board Assembly

Introducing Pliable PCB Assembly – the versatile solution for all your electronic needs! Our state-of-the-art technology enables us to create circuit boards that can be bent, shaped, and twisted to fit into any device. From healthcare devices to digital cameras and mobile phones, our Pliable PCB Assembly provides the perfect combination of flexibility and durability.

Thick Copper Circuit Assembly

Introducing Thick Copper Circuit Assembly – the reliable solution for your high-current electronic needs! Our cutting-edge technology allows us to mount Thick Copper Circuit Boards that can handle large currents, making them ideal for use in a variety of industrial machines, automobiles, trains, and robots.

Blood glucose meter

Experience the future of blood glucose monitoring with our cutting-edge device that seamlessly combines high accuracy and Bluetooth communication. With a lightning-fast measurement display in just 5 seconds, our device uses advanced blood detection technology to ensure unbeatable precision. Thanks to its 0.3 µL micro sampling, you only need a small blood sample to get the job done. Say goodbye to bulky and inaccurate devices and hello to a new era of blood glucose monitoring.

Dual Inline Package (DIP)

CERTIFICATIONS

ISO 13485:2016

ISO 14001:2018

COMPLIANCE WITH GLOBAL STANDARDS

21 CFR 820

It ensures that all medical devices created and developed within the US market are safe and follow satisfactory quality processes at all stages of development. This is important for manufacturers to ensure they are producing medical devices which are effective and assure patient safety.

MDD (93/42/EEC)

Defines a “Medical Device” as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings

IVDD (98/79/EC)

In vitro diagnostic medical devices (IVDs) are subject to the European Directive 98/79/EC (IVDD). A subgroup of medical products, their market access, use, and market surveillance is regulated.

CGMP

CGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

KGMP

KGMP means Korean good manufacturing practices requirements specified by KFDA regulations applicable to the Manufacture of the Licensed Product for Commercialization.

MDSAP

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

COMPLIANCE WITH SOCIAL ACCOUNTABILITY

SMETA (SEDEX Members Ethical Trade Audit)
Wal-mart Compliant