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A provider of contract manufacturing, development and engineering of radio frequency (RF) welded products, Genesis Plastics Welding recently achieved its ISO 13485:2003.
Indianapolis, Indiana (PRWEB) March 04, 2013
A provider of contract manufacturing, development and engineering of radio frequency (RF) welded products, Genesis Plastics Welding recently achieved its ISO 13485:2003. With this certification initiative, Genesis customers are assured of the company’s continued dedication to quality-focused systems and processes for product delivery.
“Achieving ISO 13485:2003 certification is a critical milestone for Genesis Plastics Welding,” says Tom Ryder, president and CEO of Genesis. “Receiving this certification furthers our position as a one-stop partner for all development and manufacturing of medical device equipment using RF welding and heat sealing applications.”
The ISO 13485 is based on ISO 9001 standards, but includes requirements specifically for medical devices including regulatory requirements, effectiveness monitoring, records management, work environment (sterile, cleanroom, etc.), risk analysis and design and development validation. The review was performed by SGS North America, Inc. according to ISO 13485:2003 requirements, and focused on Genesis’ role as a contract manufacturer providing heat sealing applications including assembly and packaging.
For more information, call 317-485-7887 or visit http://www.GenesisPlasticsWelding.com.
About Genesis Plastics Welding
Genesis Plastics Welding is an ISO 13485:2003 certified contract manufacturer providing radio frequency (RF) welding and heat sealing applications of plastic products for military, medical and other industries. Products include military helmet pad systems, blood pressure cuffs, inflatable bladders, hot and cold therapy devices, compression therapy sleeves, disposable heating blankets and drainage bags. 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. For more information visit http://www.genesisplasticswelding.com.
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