As experts in the medical device field, we recognize the risks associated with the development of electronic medical devices. Therefore, Omnitek adheres to the highest standards required by the medical industry and provide our clients with the necessary documentation and resources for them to succeed. We have an array of experiences with innovative medical applications, where the solutions required high-reliability results, risk assessments, documentation, and FDA approvals. Whether a project requires turnkey development, partial development, or a proof of concept, Omnitek is there to provide the electronics to keep patients alive by design.
- Design Process Conforming to FDA Requirements
- Design to IEC 60601 Medical Device Standard
- Completed Documentation for 510K filling