Five Star Companies, a Mass.-based, contract manufacturer of implants and instrumentation and a provider of surgical instrument repair, has announced the successful certification to ISO 13485:2016—the latest version of the quality management system standard for medical devices.
 
Recognized globally as a benchmark for medical device quality management systems, the 2016 revision is the first in over ten years, and replaces the 2003 version utilized in over 26,000 manufacturing locations worldwide. The major changes address risk-based approaches to product development and processing, enhanced controls over suppliers, and verification processes for linked devices.
 
“Five Star Companies is committed to ensuring that our quality management system for medical device manufacturing is able to demonstrate compliance with the latest standards and provides validation of our customers’ requirements.” said David Cabral, president of Five Star Manufacturing division. “This dedication to quality and proactive pursuit of the latest industry requirements exhibits Five Star Companies’ promise to customer satisfaction.”
 
For additional information about Five Star Companies’ capabilities and services, visit www.fivestarcompanies.com.