Medical Device Contract Manufacturer You Can Trust
With manufacturing facilities of over 32,000 sq. ft. of production capabilities, Corgenix can meet your needs, from pilot/clinical builds to full scale production. Our tightly controlled QSR systems are FDA compliant and ISO 13485:2016 certified to ensure consistent quality management for your finished devices and components.
Corgenix provides comprehensive, integrated contract manufacturing services for finished Class I,II and III therapeutic and diagnostic medical devices along with formulation, filling and packaging services. We focus on quality and service to produce medical devices and products that meet the demands of today’s global market. At Corgenix, we have the manufacturing capabilities to ensure quality, speed and a smooth transition into the marketplace.
Corgenix’s 30 years of experience is the result of interest from medical device companies and others looking to decrease manufacturing costs without sacrificing quality, compliance, intellectual property protection, or patient satisfaction. Corgenix enables medical device companies and others who want to develop and manufacture products to do so without the expense of establishing their own production facilities, or to meet increased demand without increasing the existing physical plant. As an FDA compliant outsourced medical device and product contract manufacturer, Corgenix is able to provide reliable and regulated conditions for the safe and cost-effective production of today’s cutting–edge medical device technologies.
Corgenix has established its leading reputation via operational focus and experience in dealing with medical device and product launches with rapid time to market expectations.
The varied needs of its customers are consistently met by an experienced team where safety, compliance and focused Design History Record (DHR) management exist. With intense focus on new product introductions, Corgenix has been able to successfully and cost effectively list and launch new products for a broad range of medical and innovation companies.