With our Design & Development process, our clients can be assured that we take each step with a quality controlled methodology. We are FDA and 13485 certified, and are committed to providing service under these qualifications.
QUALITY CONTROLLED METHODOLOGY
Meet Your Quality Needs
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.
Analysis & Testing
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 with 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.
As a contract service provider, we are accustomed to meeting the detailed needs of our clients. This includes qualifying Poly-Med, Inc. as a supplier of goods or services through a desk or on-site audit. If you are interested in qualifying Poly-Med as a supplier, please contact us for more details.
Validation & Production
Almost every process performed at Poly-Med, Inc. is custom-tailored to our client’s needs. To assure the highest quality level for each manufactured product, we transition designed products through a robust development cycle that includes equipment and process validations. The result is reliable and reproducible processes that consistently meet client requirements.
Customized Manufacturing Strategy
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 unique requirements to assure the highest level of quality is provided to our clients.
Formulate a Strategy
To develop new products, we follow the standards outlined in the ISO design control strategy. Our goal, is to use these standards as guidelines throughout the phases of product development; in identifying client requirements, accurately evaluating prototypes against these requirements, and ultimately, the transfer of the product to manufacturing. With these control guidelines in place, we can ensure components and finished products stay inline with client needs.