According to International Organization for Standardization, the ISO 13485 Medical Devices is “Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has been revised, with the newest version published in March 2016.”
As ISO discusses, “Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.”
If you are in the medical device business, make sure you are working with a team that holds the ISO 13485 certification for your PCBa. Fill out an RFP and let us help you.
Surya Electronics Inc.
Fabricating the brain-power running your product at World Class Speed with Pinpoint Precision
Since 1983 ISO 13485 suryaelectronicsinc.com 630 858 8000
