PLITEK® is proud to announce obtaining ISO 13485:2016 Certification. Our decision to work towards ISO 13485:2016 Certification demonstrates our commitment to provide our clients high-quality products and services and our ongoing investment in meeting the rigorous demands of the medical device industry by manufacturing the highest quality medical device components.
ISO 13485:2016 is a medical device Quality Management System (QMS) regulatory standard, derived from internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 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 an expert manufacturer of precision die cut components and converted materials to a broad range of markets. Through our expansive converting capabilities, we manufacture products and components from thin gauge films, plastics, foams, and adhesives. Our customers turn to us for streamlined manufacturing, material sourcing, and process control. We will work with you side-by-side from design assistance, material selection, and prototyping to high volume production. Our unique combination of engineering expertise, materials science, prototyping capabilities, ISO Class 8 clean rooms, and vertically integrated manufacturing allow us to provide innovative solutions for even the most complex converting requirements.