Developing complex, state of the art medical devices and products requires meeting the highest regulatory standards and certifications. Conductive Technologies has 45 years of experience working with companies whose products are subject to regulatory oversight and can be a valuable partner to creating and manufacturing your product in compliance with these standards.
Our quality system is certified to the ISO 9001 (PDF), ISO 13485 (PDF) and EN ISO 13485 (PDF) standards and is compliant to FDA 21CFR820 and cGMPs. Conductive Technologies is registered with the FDA as a contract manufacturer.
As a single source provider, CTI can meet regulatory requirements for design, manufacture and packaging of your custom product. CTI can support your product development cycle from concept through validation. CTI can further assist our customers through donor studies with the support of our Ph.D. scientists and on staff medical technicians to assist in your regulatory submissions.