Quality Control and GMPs

All manufacturing work is performed in controlled environments following cGMPs. The Quality System assures that all regulatory / cGMPs requirements are met through routine Quality Management Review, auditing and validations. The Quality System effectiveness is continuously monitored to assure that manufacturing process records are complete and accurate to meet Regulatory requirements and that all devices produced are of a consistently high-quality.

In accordance with United States federal regulatory requirements, Bates Industries, LLC. is a registered medical device establishment.