J-Pac Medical, a manufacturing and packaging outsourcing partner to medical device and diagnostic companies, has received its ISO 13485:2016 certificate ahead of the industry’s 2019 deadline.
Somersworth, NH (December 6, 2017) – J-Pac Medical, a manufacturing and packaging outsourcing partner to medical device and diagnostic companies, has just received its certificate of registration for ISO 13485:2016. ISO 13485 is an internationally agreed upon standard that defines the requirements for a quality management system for medical device industry.
The new standard that J-Pac just received, 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.
While the rest of the industry is not required to adhere to the new standard until February of 2019, J-Pac Medical has achieved certification well in advance. “Safety and quality is non-negotiable in our industry. As an external manufacturer to the medical device industry we were determined to show our commitment to our customers by meeting this more rigorous quality standard now rather than later,” said Jeff Barrett, President and CEO of J-Pac Medical. “Medical device OEM’s can be confident that J-Pac will help them reduce risk by meeting the most stringent and up-to- date quality system regulations in the world.”
About J-Pac Medical
J-Pac Medical is a trusted manufacturing and packaging outsourcing partner to medical device and diagnostic companies seeking to deliver superior quality, improve time-to-market and simplify the supply chain for single-use medical devices. With more than 30 years of experience in complex thermoplastic devices and packaging, J-Pac Medical has the unique technology that allows it to manufacture anatomically correct, class III implantable textile assemblies, lab-on-chip reagent blisters, and complex thermoformed packaging. Additionally, the company offers full-service supply chain management, packaging and sterilization. The largest medical device companies in the world rely on J-Pac Medical to help meet the most difficult development, manufacturing, and logistics and supply chain challenges.