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.
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.
Plitek Clean Room Die Cutting and Converting
Published by Plitek, LLC on Jun 15, 2022
