Quality

At Biomerics, we model our Quality Management System on the founding principles of ISO 13485:2003 and 21 CFR Part 820 - that quality management is a process.  We understand that continuous improvements through Lean Manufacturing are key to developing robust, high value, repeatable processes.  We are committed to partnering with our customers to assure that our products and quality system meet their needs.  To learn more about our quality system, services, and regulatory support, please review the following links:

	Our Quality Commitment Biomerics manufactures products that meet or exceed our customers' expectations.  As a team, we continually strive to improve our processes and products and provide superior service to our customers.
	Quality Assurance Biomerics facilities are ISO 13485:2003 and ISO 9001:2008 registered.  Learn more about our quality systems, Lean Manufacturing principles, validation processes, and quality problem solving tools in this section.
	Quality Lab Biomerics operates on-site quality laboratories to provide inspection and certification of materials and finished goods.
	Regulatory Compliance Services Biomerics provides regulatory compliance services to support our materials and medical devices.  We have a deep knowledge of medical regulations and standards, with experience in biocompatibility, validations, and submissions to the FDA.