SkyWater Achieves ISO 13485 Quality Certification for Medical Devices

Accelerates customers’ migration to production in the fast-growing
biochip market

Technology Foundry
, the trusted innovation partner for tomorrow’s
most advanced technology solutions, today announced its certification to
the ISO 13485 standard which specifies requirements for a comprehensive
quality management system that supports the design and manufacture of
medical devices. The ISO 13485 standard outlines business process
requirements for manufacturers supplying solutions into medical
applications and serves to verify compliance with quality standards
which minimize risks potentially affecting patient health or safety that
stem from manufacturing quality issues. By achieving this standard,
SkyWater is well-positioned to meet the increasing demand for
semiconductor content in this rapidly accelerating market. In addition,
SkyWater’s geographic location in the Twin Cities, known as a healthcare
technology hub, provides direct access to several leaders in this field.

The ISO 13485 certification provides confirmation of quality processes
SkyWater has developed in-house to support its focus on medical device
fabrication such as DNA sequencing and other applications in the design
and development stage. The new certification will streamline customers’
development cycles and accelerate their migration to production for a
wide range of emerging biomedical market segments including implantable,
wearable and rapid medical diagnostic devices. According to Inkwood
Research, the global biochips market is estimated to generate net
revenue of approximately $62.82 billion by 2027 growing at a CAGR of
20.63% during the forecast period 2019-2027.

“Obtaining ISO 13485 compliance certification marks an additional
commitment to our growing customer base. The certification was quickly
achieved by leveraging many processes already in place which support our
existing quality management certifications including those critical to
servicing the automotive industry,” said Thomas Sonderman, President,
SkyWater Technology Foundry. “Our business is focused on streamlining
the product development process for customers across our business units.
Adding this qualification strengthens our ability to extend more of our
innovation services into medical markets.”

About SkyWater Technology Foundry

SkyWater is a solely U.S.-based and owned, DMEA-accredited Technology
Foundry, providing custom design and development services, exclusive
design IP, and volume manufacturing for integrated circuits and micro
devices. The Company’s world-class operations and unique processing
capabilities enable mixed-signal CMOS, rad-hard and ROIC solutions.
SkyWater’s Innovation Engineering Services empower development of
superconducting and 3D ICs, along with carbon nanotube, photonic and
MEMS devices. SkyWater serves customers in growing markets such as
aerospace & defense, automotive, cloud & computing, consumer,
industrial, IoT and medical. For more information, please visit:


SkyWater Company Contact: Ross Miller | 952.851.5063 | [email protected]

Media Contact:
Lauri Julian | 949.280.5602 | [email protected]

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