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.