Quality & Regulatory

Quality Policy

FOBI Medical is committed to providing quality products and services that meet or exceed customer expectations. We utilize our quality management system to ensure continuous improvement, satisfy the needs of our customers and improve the overall success of the company.

ISO 13485 FOBI Medical Quality

ISO 13485:2016

FOBI Medical is committed to the highest standard and has been ISO 13485:2016 certified for over 7 years. We are audited by an external organization to ensure our compliance, reliability and to better satisfy the needs of our customers.

FDA FOBI Medical Quality

FDA Registration

Since we service and distribute medical devices and accessories, FOBI Medical is registered with the US Food & Drug Administration (FDA).  

Texas DSHS

Complying with regulatory bodies is a priority here at FOBI Medical! As such, we are also registered with the Texas Department of State Health Services (DSHS).

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