Documentation and Regulatory

Documentation and Regulatory

Omnica has used a proven process to efficiently turn concepts into medical devices for nearly three decades. Central to this method is the creation and maintenance of history files documenting design changes and iterations.

Our model gives us the capability to comply with 21 CFR 820 and ISO 13485 development guidelines. At the client's request, and according to their specific needs, we can generate Design History and Technical files with accompanying Design Control procedures and templates. In this way we can remain responsive and flexible while offering a customized and comprehensive project documentation package.