Our design & development teams will partner with you through all stages of device development, from initial disclosure and protection of Intellectual Property to design for manufacture activities. With numerous patents and proprietary processes under their belt, our team is comprised of experts in research, product development, high volume manufacturing, and regulatory affairs professionals that bring years of experience to support our customers.
Our quality management system is designed to navigate any regulatory path requirements and support the development of any new device technology. Our Athens campus is an FDA registered facility utilizing quality systems that are compliant with FDA QSR regulations. We are an ISO 13485:2003 certified and Brazil ANVISA certified facility. We comply with USFDA CFR 21 820 and Japan MHLW Ministerial Ordinance 169.
We have both pilot manufacturing, clean room manufacturing and full scale high volume manufacturing capabilities at our Athens campus. Our manufacturing technologies include:
We can be your partner in developing a comprehensive regulatory strategy for your new medical device. Our regulatory team will be an active participant on the project team from the initiation of the project providing guidance and regulatory opinion. Once the design has matured to the appropriate point, they will craft a regulatory submission plan and the requisite documentation to support the various submissions (Pre-Submissions, 510(k)s, 513(g), Technical File, etc) and guide and/or manage the interaction with the regulatory agencies.