Officials from Creation Technologies announce that one of its two facilities in Ontario, Canada, has received registration approval from the Food and Drug Administration (FDA). The Mississauga, Ontario, operation becomes the fourth Creation Technologies manufacturing location in North America to be FDA-registered.
Creation Technologies continues to partner with more and more leading Medical Device OEMs requiring full-service solutions. Twelve of the company’s 13 manufacturing business units are ISO 13485-certified, and its Design Services business unit has both ISO 13485 and ISO 14971 certifications.
“Requirements for the Medical Devices that Creation designs and builds are becoming increasingly complex,” says Creation–Mississauga General Manager, Mark Krzyczkowski. “More and more of our customers are taking advantage of the full suite of services that we offer, and so our grasp of their needs has had to become very sophisticated.”
“For our Medical customers,” Krzyczkowski continues, “this has meant a commitment to significant expansion of our design, quality and regulatory systems and capabilities, of which an understanding of the FDA approval process is certainly a part.”
“Our Purpose of ‘Enriching Lives’ aligns well with the business philosophies of our OEM partners in the Medical Device industry,” states Executive Vice President, Andy Hyatt, whose expertise in the medical industry spans several decades. “A strong cultural fit between organizations continues to be key in developing new relationships.”