FDA Guidance on Additive Manufactured Medical Devices: Basics
The first article dedicated to additive manufactured medical devices provides a brief overview of the technology itself and also describes the core aspects of the existing regulatory framework.
Read the full article at: www.regdesk.co
Who We Are
Omnica Corporation is a privately-held design, engineering, and medical product development firm located in Irvine, California. The 28-person company is staffed with full-time employees and has been in operation since 1984. Our speciality is custom product development for the medical industry and industrial fields.
Our expertise is developing complex medical devices.Technical personnel at Omnica includes designers, mechanical engineers, electronic and software engineers, advanced R&D specialists, regulatory staff (for FDA documentation), machinists and model makers.