Our quality assurance standards are ingrained into the very core of our company: the organizational structure, responsibilities, procedures, processes, and resources used.
Poly-Med, Inc. is an FDA registered and ISO 13485 compliant 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.
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.
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.
Our absorbable & synthetic biomaterials can be converted into a variety of implantable medical devices for markets that include soft tissue reinforcement & scaffolds, orthopedics & craniomaxillofacial, and advanced wound & burn tissue scaffolds.
Our absorbable & synthetic biomaterials may be processed into hernia meshes, plastic surgery meshes, macroporous tissue scaffolds, & barrier applications.
Our absorbable & synthetic biomaterials can be converted into load-bearing sutures, tendon meshes & bands, and bone scaffolds, as well as non-load bearing nanofibrous tissue scaffolds.
Our absorbable & synthetic biomaterials may be converted into nanofibrous tissue scaffolds to facilitate the healing process, as well as converted into barrier applications to augment fluid exchange.
Our raw absorbable & synthetic polymer may be purchased to be converted via injection molding into solid implantable medical devices.
We support client medical device ideas with advanced absorbable materials and processing.
Absorbable polymers can transform the healing process by temporarily restoring functionality in targeted areas. After use, they resorb within the body without a trace, minimizing the need for follow up surgical procedures.
Our polymers can be extruded into monofilament fibers, multifilament yarns, or films as inputs into biomedical textile applications. Don’t design for a filament, select the filament for your design.
Our polymers can be constructed into a variety of fibrous articles and medical textiles. More polymers equal more responsive designs, with better outcomes. Don’t design for a polymer, select the polymer for your design.
Regenerative scaffolds aim to mimic the physical, chemical, mechanical, and biological cues observed in a normal tissue environment. This technology can be tailored to partially, or fully, absorb during the healing process.
Create lattice-based architectures with 3D-printed absorbable implants via filament-based and resin-based approaches that are inaccessible via injection molding.
Our polymeric materials can be used as excipients to allow for facile processing with active pharmaceutical ingredients (APIs) and customizable continued-release profiles for combination medical devices.
Looking for a trustworthy & competent partner to co-create and manufacture your next-generation absorbable implant? Contact our team to speak to an expert.
We provide an adaptable approach to customer needs for any medical application. How can we help you?
Interested in learning about Poly-Med's bioresorbable polymer portfolio and processing capabilities? Complete this form to receive the catalog.
We provide an adaptable approach to customer needs for any medical application. How can we help you?
Please provide your name and email to view our ISO Certificate.
Please provide your name and email to view our Max-Prene® Polymer Data Sheet.
We provide an adaptable approach to customer needs for any medical application. How can we help you?
We provide an adaptable approach to customer needs for any medical application. How can we help you?
Please provide your name and email to view our Photoset® 311 Resin Data Sheet.
Please provide your name and email to view our Dioxaprene® Polymer Data Sheet.
Please provide your name and email to view our Glycoprene® Polymer Series Data Sheets.
Please provide your name and email to view our Lactoprene® Polymer Series Data Sheets.
Please provide your name and email to view our Aquaprene® Polymer Data Sheet.
Please provide your name and email to view our Lactoflex® 7415 3DP Filament Data Sheet.
Please provide your name and email to view our Dioxaprene® 100M 3DP Filament Data Sheet.
Please provide your name and email to view our Lactoprene® 100M 3DP Filament Data Sheet.
Please provide your name and email to view our Strataprene® 5525 3DP Filament Data Sheet.
Please provide your name and email to view our Caproprene® 100M 3DP Filament Data Sheet.
Please provide your name and email to view our Strataprene® Polymer Series Data Sheets.
Please provide your name and email to view our ISO Certificate.