(SAN DIEGO, CA – June 4, 2009) Invetech, a leader in product development and custom automation for the medical, industrial and consumer markets, recently received the International Organization for Standardization certification for the San Diego facility, ISO13485:2003, reinforcing Invetech’s signature development processes and quality management system.
President of Invetech, Dr. Fred Davis, explains, “Our clients rely on us to deliver a very high standard. This certification shows Invetech’s commitment to meeting client and regulatory requirements, applying risk management techniques and maintaining systematic quality processes.”
The assessment and certification was conducted by BSI, the leading global provider of management systems assessment and certification solutions. The certification is a cornerstone in ensuring that medical device products designed and developed in Invetech’s San Diego facility consistently meet client and customer needs.
“Our clients are always welcome to audit us, but being ISO13485 certified reduces the burden for them – reinforcing our commitment to process, quality and product safety,” said Davis.
Invetech’s San Diego facility is now formally equipped to design and develop instrumentation, medical devices and consumables for diagnostics, patient treatment, analysis, materials handling and drug development. Invetech’s Melbourne manufacturing facility, which manufactures instrumentation for three of the world’s top ten diagnostics companies, is also ISO13485:2003 certified.