Investing in processes, technology, and people, Pres-Tek Plastics pledges to bring the highest quality to every step of the development and manufacturing process.
With GMP-based manufacturing and an ISO 13485:2016 certified quality management system, Pres-Tek Plastics is dedicated to consistently exceeding our customers' expectations for medical component fabrication. We ensure the suitability and effectiveness of our Quality Management System through continuous improvement, our commitment to meeting quality objectives, and ensuring compliance with regulatory requirements at all levels.
Environmental monitoring is conducted and statistically trended to assure compliancy to ISO Class 8 cleanroom requirements and to assure that our clients products are manufactured under controlled conditions. All processes are centrally controlled by a highly customized ERP software system. The system allows for complete traceability, document control, quality control, as well as inventory management.