J-Pac Medical Receives ISO:13485:2016 Registration Ahead of Schedule

J-Pac Medical, a value added partner specializing in implantable textiles, turnkey packaging, thermoformed packaging and manufacturing services for medical devices, received its certificate of registration for ISO 13485:2016 ahead of the industry’s February 2019 deadline.

ISO 13485 is the standard that defines the requirements for quality management systems. ISO 13485:2016 has a greater emphasis on risk management and risk-based decision making. It also reflects changes related to the increased regulatory requirements for organizations in the supply chain. It is a major update from the 2003 standard and is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations. 

Source: J-Pac Medical