Engenious Design

Our engineering team is a booster rocket for accelerating medical device design; we help clients launch products with certainty. We fold into client development teams, working alongside as design partners. Our uniquely-integrated approach means lower-risk development and more transparency. Our team’s portfolio includes FDA Class II, and PMA devices. We plan, specify, architect, design, prototype, verify, validate and transfer devices to production. Our focus is on electronic, mechanical and embedded software medical devices. Because of our medical device focus, we have an ISO:13485 / 21CFR820 - compliant quality system.