"Many of our products directly touch patients, so safety and quality are integral for the medical devices we develop and manufacture," said Benjamin Harp, president of Polymer Medical. "Earning ISO 13485 certification means customers can count on the fact we've developed and implemented processes that adhere to QMS standard."
Based on the ISO 9001 process approach to quality management, the primary objective of ISO 13485 is harmonizing medical device regulatory requirements for QMS. The standard is specific to organizations providing medical devices or services, regardless of the type or size of the organization.
Plastics industry veterans Harp and Tom Rybicki, vice president of Operations for Polymer Medical, launched the firm in April 2024 to provide healthcare and biosciences clients with contract injection-molding and assembly services. The company's focus is producing critical drug-delivery systems, medical disposables like syringes, medical devices for home healthcare to orthopedics, specialty packaging, and pharmaceutical disposables among other services.
"We commend Polymer Medical on prioritizing quality in medical devices by achieving certification to ISO 13485," stated Sameer Vachani, senior director of NSF-ISR. "Companies certified to the ISO 13485 standard show they are actively implementing quality management systems in their organization, supporting the health and safety of their workforce, customers, and end users."
Orchard Park, N.Y.-based Polymer Medical is a world-class provider of contract plastic injection molding and assembly for healthcare and biosciences. Its services include in-house tool building, tool transfer, product enhancement, and finished medical device assembly. For more information, visit https://polymermedical.com/
NSF International Strategic Registrations (NSF-ISR) offers a comprehensive portfolio of management systems registration solutions to meet the demands of the global marketplace. NSF-ISR is the largest automotive registrar in North America and is recognized by the International Automotive Task Force (IATF) to provide IATF 16949 registrations in the automotive sector. NSF-ISR also provides registrations for the following programs: ISO 9001, ISO 14001, ISO 45001, AS 9100/10/20, ISO 13485, ISO 20000-1, Responsible Care (RC) 14001 and Responsible Care Management Systems (RCMS), as well as greenhouse gas verification/validation.