The Quality Regulatory Engineering department oversees and provides analysis of the entire quality management system at all stages to maximize the quality of the process itself and the products it produces to ensure we remain in compliance with appropriate regulatory standards. We assist and support every department/employee at FHC with regards to Quality.
Additionally, we handle the registrations of our products in the US and Globally and are the host to Auditors. We handle customer complaints, root cause analysis, and any market withdrawals or medical device reporting required.
The Quality/Regulatory/Engineering Group also design systems by which production quality may be checked against in an ongoing process and works within the EC system to update existing production prints and new design of electrodes, tubes and cables.
Finally, we work with the Operations team to implement any new testing/inspection criteria or assembly methods we may develop.
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