PartnerTech Inc. Achieves ISO 13485 Certification

Share Article

ISO 13485 certification creates new opportunities for manufacture of medical devices and related industry products in the United States.

News Image
Gaining this certification is an integral part of our commitment to provide complete solutions for our clients. Preparing for the ISO 13485 audit was a team effort that will insure a quality manufacturing process for our medical clientele in the U.S.

PartnerTech Inc., NA, a wholly owned subsidiary of PartnerTech AB, a leader in systems integration and electronic manufacturing, has received the ISO 13485 certification. This certification demonstrates excellence in providing manufacturing services for medical device and related services according to international standards.

By achieving ISO 13485, PartnerTech Inc. proved the highest level of requirements in a quality management system designed specifically for the manufacture of medical devices and related services to consistently meet customer and regulatory requirements. PartnerTech’s Lawrenceville, Georgia facility also houses a Class 7 cleanroom which provides a controlled work environment for certain medical device manufacturing.

The ISO 13485 certification opens the opportunity for PartnerTech’s North American location to begin serving several existing clients and new business in the manufacture of medical devices and related services. PartnerTech Inc., NA, already held ISO 14001 and 9001 certifications. With the addition of ISO 13485, the opportunity for manufacture of several products in a single facility is presented providing a distinct advantage in optimizing supply chain for clients.

“Gaining this certification is an integral part of our commitment to provide complete solutions for our clients. Preparing for the ISO 13485 audit was a team effort that will insure a quality manufacturing process for our medical clientele in the United States,” said Gary Bruce, President and Managing Director of PartnerTech Inc., NA.

About ISO 13485
The ISO 13485 certification is significant in that it creates a management system providing a framework for compliance with various global regulatory requirements along with customer requirements, and with an emphasis on risk management and maintaining effective processes. Implementing ISO standards offers benefits in cost savings, improved customer satisfaction and increase sales.

About PartnerTech AB:
PartnerTech AB is a global industrial partner offering customized solutions throughout the product lifecycle, from product development to manufacturing and aftermarket services, in a number of market areas such as MedTech and Oil & Gas. With almost 1,400 employees at its plants in Sweden, Norway, Finland, Poland, the UK, the United States, and China, PartnerTech reports annual sales of more than SEK 2,2 billion (approx. $335MM). PartnerTech AB, the parent company, is headquartered in Malmö, Sweden and is listed on the Nasdaq OMX Stockholm Exchange.

About PartnerTech Inc.
PartnerTech Inc., located in Atlanta, GA, is a wholly owned subsidiary of PartnerTech AB of Sweden and offers expertise in systems integration and postponement manufacturing, making them an obvious choice for companies seeking to lower costs through better forecasting, supply chain alternatives, and efficiencies in distribution and management of capital investments. Services are tailored to fit the needs of each client, with regard to scaling production, shipping expertise, and sourcing methods.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Gary Bruce - President and Managing Director, PartnerTech Inc., North America

Kelly Powley - Marketing Manager
@ContractMfgAtl
since: 02/2014
Follow >
Visit website