24-24 April 2023
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Plitek, LLC
/ 15 Jun, 2022
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Plitek obtains ISO 13485:2016 Certification

PLITEK®, contract converter/manufacturer of precision die cut components and converted materials, is proud to announce obtaining ISO 13485:2016 Certification. The decision to work towards ISO 13485:2016 Certification demonstrates their serious commitment to provide clients with high-quality products and services. This achievement proves the 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 13485:2016 guides medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes.

The standard 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 their expansive converting capabilities, they manufacture products and components from thin gauge films, plastics, foams, and adhesives. PLITEK® customers continually turn to them for streamlined manufacturing, material sourcing, and process control. They work with clients side-by-side from design assistance, material selection, and prototyping to high volume production. The unique combination of engineering expertise, materials science, prototyping capabilities, ISO Class 8 clean rooms, and vertically integrated manufacturing allows PLITEK® to provide innovative solutions for even the most complex converting requirements.

To learn more about PLITEK®'s converting capabilities visit: www.Plitek.com

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