We recognize quality systems are essential in medical device manufacturing and commits significant investment to continually cultivate quality systems that serve leading medical device OEMS.

The ISO Notified Body, LLOYD’S REGISTER QUALITY ASSURANCE (LRQA), certifies INTEGRA QUALITY MANAGEMENT SYSTEMS (QSM) to the requirements of ISO-9001:2008 and ISO-13485:2003. QSM, developed on best practices of Lean Manufacturing Philosophy and Six Sigma, affords maximum flexibility to incorporate unique customers’ requirements and procedures. QSM undergoes audits by external third parties every month and welcomes the audits as an opportunity for constructive feedback for the implementation of Continual Improvement.

Quality Policy

Integra Biotechnical defines “Quality” as “Conformance to Requirements“ and strives to meet or exceed customers’ requirements defined as product quality and on-time delivery. The achievement of these goals demands that product quality be inherent in the design of the product and monitored throughout the manufacturing process.

Integra’s management commits to providing the support and resources necessary to ensure quality goals are consistently met and to continually improve the effectiveness of the Quality Management System.

View our Quality Systems Manual

MHLW, Japan

Integra Biotechnical received certification as an Accredited Overseas Manufacturer of Medical Devices per Ministry of Health, Labor, and Welfare (MHLW, Japan).