Quality
Our quality assurance standards are ingrained into the very core of our company: the organizational structure, responsibilities, procedures, processes, and resources used.
Excellence in medical device development
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.
ISO Registered
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 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.
Client Audits
As a contract service provider, we are accustomed to meeting the detailed needs of our clients. This includes qualifying as a supplier of goods or services through a desk or on-site audit.
Validation & Production
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.
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 requirements to assure the highest level of quality is provided to our clients.
A Strategic Approach to Quality
To develop new products, we follow the standards outlined in the ISO 13485 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, in the transfer of the product to manufacturing. With these control guidelines in place, we can ensure components and finished products stay in line with client needs.
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