Genesis Medical Facility.Genesis's third class 7 cleanroom at its facility near Indianapolis, Indiana, in the USA.
US contract welder Genesis Plastics Welding has added a new class 7 cleanroom at its facility near Indianapolis, Indiana. The investment brings the total number of class 7 clean rooms to three.
“Recent national mandates have made infection prevention a leading concern of health care providers, creating this increasing need for these products,” says Genesis Plastics Welding CEO Tom Ryder. “We are in a great position to help supply products to meet those increasing demands.”
Genesis’ expertise in RF welding, including its proprietary heat-sealing technology, ecoGenesis, enables them to manufacture cost-efficient, greater integrity, phthalate-free products.
“Recent additions to our staff, including engineering experts in product and process development, have enhanced our research and development abilities; we are serving clients from concept to commercialisation,” says Ryder.
Genesis manufactures a wide array of products including blood pressure cuffs, instrument covers, media reservoir bags, inflatable bladders, hot and cold therapy devices, compression therapy sleeves and coolant bags, and fluid drainage bags. Members of the Genesis team, including Ryder, will be updating industry leaders regarding the company’s expanded capabilities in manufacturing single-use, disposable medical products at the Medical Design & Manufacturing (MD&M) East, June 18 - 20 in Philadelphia, USA.
In February 2013 Genesis achieved its ISO13485 certification, demonstrating that the company has met the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
“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 according to ISO 13485:2003 requirements, and focused on Genesis’s role as a contract manufacturer providing heat sealing applications including assembly and packaging.