Multiple Function Device Products: Policy and Considerations | FDA
This guidance explains FDA’s policy for multiple function device products, including principles, regulatory approach, and examples of the application of these policies.
Sourced through Scoop.it from: www.fda.gov
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.