Tom Ryder, president and CEO of Indianapolis-based medical device contract manufacturer Genesis Plastics Welding, Inc., announced today the successful completion of Genesis’ ISO 13485:2016 certification.
“Achieving the 2016 version of the ISO 13485 certification only furthers our position as a collaborative contract manufacturing partner for global medical device OEMs,” says Ryder. “I’m extremely proud of my team on the achievement.”
Originally certified ISO 13485:2003 in early 2013, upgrading to the 2016 version of the certification is part of the company’s continued dedication to quality-focused systems and processes. As a leading provider of contract manufacturing and development services of radio frequency welded medical devices, a dedication to continuous improvement is at the foundation of Genesis’ success in the industry.
“In our immensely regulated and competitive industry, adhering to the latest ISO standard is essential in the continued delivery of quality medical device products to customers across the globe,” says Ana Dawes, quality assurance manager of Genesis Plastics Welding. “I’m pleased to have completed this milestone, ensuring Genesis’ quality management system meets the highest level of medical device controls.”
ISO 13485 is the international standard that governs the manufacture of medical devices and is rooted in ISO 9001. It includes requirements specific to medical device, including regulatory requirements, effectiveness monitoring, records management, manufacturing environment, risk analysis and design/development validation. The first edition was published in 1996 with updates released in 2003 and 2016. Genesis’ ISO 13485:2016 certification was performed by third-party entity SGS North America Inc.
About Genesis Plastics Welding:
Genesis Plastics Welding is an ISO 13485:2016 certified contract manufacturer providing radio frequency (RF) welding and heat sealing applications of plastic products for medical, military and other industries. Genesis’ proprietary heat sealing technology, ecoGenesis™, allows RF plastics welding of very thin gauge (down to 0.001 inch) polyethylene, polypropylene and low-loss polymers and can facilitate polyvinylchloride (PVC) and polyurethane (PU) replacement with phthalate-free plastics.