Medical Device Industry

Omnex specializes in the Medical Devices Industry and has conducted many implementations for US, Canadian, European and Japanese regulatory requirements. Our experience with the medical devices industries and FDA as well as with risk analysis in medical devices puts us in a unique position to help with your audit training needs. Furthermore, our training integrates both ISO 13485 and the FDA requirements. Lastly, a key ingredient to ISO 13485 depending on the product is design and process risk analysis. Omnex specializes in FMEAs for Design and Manufacturing and is a co-author to the FMEA reference manual followed by thousands of companies worldwide.

Omnex has implemented a three-site implementation of ISO 13484 in San Jose,CA, Concord, MA,, and Tokyo, Japan for TeraRecon – a medical devices supplier of software and hardware for 3D imaging systems. The implementation involved gap analysis, documentation development, implementation, audits and certification. In addition to obtaining ISO 13485 certification, the product and the management system was certified to FDA, Japanese FDA and Health Canada regulations. Omnex conducted extensive training and implementation for this organization over a nine month period. The 3rd party registrar recognized this implementation as a best-in-class ISO 13485 implementation.

Omnex has also worked with Stryker Corporation in implementing risk analysis in product realization using AQuA software in several products over a few years. Omnex implemented Process flows, PFMEAs, Control Plans, and Work Instructions in the new product development and manufacturing processes.



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