Quality Standards for Safe and Effective Medical Devices
TAMPA, Fla.--(BUSINESS WIRE)--May 25, 2017--
Sypris Electronics, LLC, a subsidiary of Sypris Solutions, Inc.
(Nasdaq/GM: SYPR), announced today that it has achieved ISO 13485
re-certification from NSF-ISR, a division of the global public health
organization NSF International.
ISO 13485 is the established quality standard for manufacturers of
medical devices and has been established by the International
Organization for Standardization (ISO), which is the largest developer
and publisher of international standards for the implementation of
Quality Management Systems.
The primary objective of ISO 13485 is to harmonize medical device
regulatory requirements for quality management systems. The standard is
specific to organizations providing medical devices or services,
regardless of the type or size of the organization. Based on the ISO
9001 process approach to quality management, ISO 13485 focuses on what
manufacturers must do to provide safe and effective medical devices.
“By achieving ISO 13485 registration, Sypris Electronics is once again
demonstrating its commitment to quality and safety,” said Andy Weinbach,
Global Managing Director, NSF-ISR.
“The ISO 13485 registration allows us to leverage our operations and
engineering capabilities to further expand our presence in the medical
device industry,” commented Jim Long, Vice President & General Manager
of Sypris Electronics. “This re-certification serves as the cornerstone
for our ongoing commitment to service the medical device industry.”
Sypris Electronics is a trusted provider of electronic solutions,
addressing customers’ needs for building complex, mission-critical
electronic and electro-mechanical devices and integrated systems. Backed
by 50 years of experience, Sypris’ engineering and manufacturing
services span our customers’ product life cycle all within a culture of
continuous improvement and Six Sigma/Lean thinking. Partners from
multiple agencies and tier one companies in Military (DoD), Space,
Medical, Civil Avionics, Telecom, and Industrial markets team with
Sypris to deliver high-reliability electronics built with strict
adherence to regulated requirements. For more information, please visit www.sypriselectronics.com.
NSF International Strategic Registrations (NSF-ISR)
offers comprehensive management systems registrations to internationally
accepted standards for quality assurance and environmental protection
for the medical device, automotive, aerospace, chemical, energy and
manufacturing industries (e.g. ISO 9001, ISO 14001, AS9100, TS16949,
etc.). NSF International (nsf.org)
is a global independent organization that writes standards, and tests
and certifies products for the water, food, health sciences and consumer
goods industries to minimize adverse health effects and protect the
environment. Founded in 1944, NSF is committed to protecting human
health and safety worldwide.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170525006075/en/
Source: Sypris Electronics, LLC
Sypris Electronics, LLC
Jim Long, 813-972-6747
