Poly-Med, Inc. is an FDA and ISO 13485 registered company that operates a manufacturing facility in compliance to 21 CFR Part 820, Quality System Regulation. Because we have the ability to see a product from design to manufacture, our quality assurance standards are ingrained into the very core of our company; the organizational structure, responsibilities, procedures, processes, and resources used. Our standards for quality management follow five critical touchpoints outlined below.
Poly-Med, Inc. is registered and routinely audited by UL against ISO 13485 quality system standards. We are also FDA registered.
Poly-Med, Inc. utilizes the latest consensus standards when developing testing protocols. This includes reviews against ISO, ASTM, ANSI, and other standards to assure that testing is performed according to the most up-to-date protocols available. Critical testing methods that are used for design validation or for product release are validated to assure repeatability.
Almost every process performed at Poly-Med, Inc. is custom-tailored to our client’s needs. To assure the highest quality standard for each manufactured product, we transition designed products through a robust development cycle that includes equipment and process validations. The result is processes that are reliable and reproducible, and that consistently meet client requirements.
Because of the custom nature of our products, each completed product that leaves Poly-Med, Inc. has unique quality requirements. Before a shipment leaves the facility, documents are reviewed and release tests performed against these requirements to assure the highest level of quality is provided to our clients.