With our Design and Development process, our clients are assured that we take each step with a quality controlled methodology. We are ISO 9001 & 13485 certified and are committed to providing service under these qualifications.
QUALITY CONTROLLED METHODOLOGY
Meet Your Quality Needs
Poly-Med is an FDA and ISO 13485/9001 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 through design to manufacture, our quality assurance standards are engrained in the very core of our company; the organizational structure, responsibilities, procedures, processes, and resources used. Our standards for quality management follow 5 critical touch-points outlined below.
Poly-Med is registered and routinely audited by UL against ISO 13485 and 9001 quality system standards.
Analysis & Testing
Poly-Med 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. Often, this includes qualifying Poly-Med 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 and Production
Almost every process performed at Poly-Med 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 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; identifying client requirements, accurately evaluating prototypes against these requirements, and ultimately, transfer of the product to manufacturing. With these control guidelines in place, we can ensure components and finished products stay inline with client needs.