AsureQuality receives certification for medical device

AsureQuality, a contract manufacturing company owned by the New Zealand government, has achieved ISO 13485:2012 certification for the manufacture of in vitro diagnostic medical devices.

The ISO certification represents a significant achievement for the company, which established a purpose-built GMP facility in Melbourne in 2007 that specialises in the production of immunodiagnostic kits, automated microplate processing and associated biologicals.

The company has traditionally been associated with food safety and quality assurance services to the primary production and food manufacturing sectors.

“This achievement is a significant milestone for AsureQuality and represents a major commitment to quality,” said business manager of diagnostics Dr Michael Zalunardo. “It is important to us to ensure the quality systems of our GMP facility continue to meet, and exceed, our customers’ expectations.”

The internationally recognised standards ISO 13485:2012 and ISO 9001:2008 for establishing quality management systems were awarded to AsureQuality by technical, safety and certification service provider TÜV Rheinland.