Dongbu HiTek earns ISO13485 quality management certification to design and manufacture medical electronics ICs

SEOUL, SOUTH KOREA: Dongbu HiTek has been certified to meet all international quality management criteria set forth in the ISO13485 standard for the medical device industry.

Adding this latest ISO certification to several others the company has earned for other industries over the past decade, the Korean foundry expects to expand its opportunities to design and manufacture highly reliable ICs for fabless companies targeting medical device manufacturers around the globe. Significantly, North America and Europe together account for more than two-thirds of the world’s medical device market.

“The ICs destined for medical devices, like those used in automobiles, must meet stricter quality and reliability standards than those manufactured for consumer products such as smart phones and flat panel displays,” said H.S. Park, Dongbu HiTek VP of Quality Reliability & Assurance. “As the world’s top specialty foundry, we see opportunities to add higher value, and thus earn higher margins, by shaping our advanced analog and mixed-signal technologies to meet specific needs of the growing medical device industry.”

No stranger to the medical electronics market, Dongbu HiTek has partnered with fabless companies to implement CMOS image sensors for endoscope and x-ray systems as well as for computed tomography (CT) scanners. Thanks to its expanding portfolio of specialized processing technologies, the company has established a foothold in implementing ICs for cutting-edge medical electronics products including cardiotachometers and MRI systems.

According to Espicom, the medical IC market is expected to reach nearly $350 billion in 2016, representing about a 7 percent CAGR from the $266 billion that the market research firm forecasts for 2012. Driving this growth is the need for more medical devices to support aging populations in advanced nations around the globe.

Specialty foundry processing
Among the advanced technologies that Dongbu HiTek has developed to establish its global leadership as a specialty foundry is the proprietary HP180 Analog CMOS process at the 180nm node.

Deploying precision-tuned active and passive components, this process is ideal for implementing data converters for medical device and metrology applications. The HP180 process also supports operating voltages up to 24V as it combines unmatched NMOS and PMOS noise performance with voltage-stable PIP capacitors and thin-film resistor matching that meet the most demanding medical device design requirements.

Other rigorous ISO certifications earned
Dongbu HiTek has logged a stellar record of meeting the strictest international quality/reliability criteria set forth by the influential British Standards Institution (BSI). As one of the very first foundries to earn the ISO/TS 16949 certification for automotive electronics in 2003, the company has steadfastly expanded its capabilities to meet the most scrupulous ISO standards.

A little over a year ago, the Korean foundry fully qualified its advanced 180nm Mixed-Signal (MS180) Process and EEPROM Intellectual Property (IP) for 0.35um BCDMOS (BD350) Process to meet the strict quality/reliability criteria set forth in the automotive AEQ-100 standard.