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.
For more information on our Quality Control and GMP practices, call Bates Industries at (518) 747-8730 ext 32 or contact us online.