Plitek, a contract converter/manufacturer of precision die cut components and converted
materials, has obtained ISO 13485:2016 Certification.
ISO 13485:2016 is a medical device Quality Management System (QMS) regulatory standard, derived from internationally recognised and accepted ISO 9000 quality management standard series. ISO 13485:2016 guides medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes.
It ensures consistency of design, development, production, installation, and delivery of medical devices.
For over 50 years, Plitek has been a manufacturer of precision die cut components and converted materials to a broad range of markets. Through its converting capabilities, Plitek manufactures products and components from thin gauge films, plastics, foams, and adhesives. The company specialises in streamlined manufacturing, material sourcing, and process control.