October 23, 2013 | Scion Medical Technologies Receives ISO 13485 Certification
Newton, MA– Scion Medical Limited was awarded ISO 13485 certification both for its China manufacturing facility in Taizhou, China and for its US subsidiary, Scion Medical Technologies LLC. ISO 13485 is an internationally recognized quality standard for medical devices.
ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It demonstrates Scion’s commitment for quality throughout the product development life-cycle and the product’s lifespan with customers.
Obtaining the ISO 13485 certification allows Scion Medical Technologies to CE Mark (Conformité Européenne) their product portfolio paving the way for entry into the European market.