PLITEK® is pleased to announce its successful ISO 13485:2016 and ISO 9001:2015 recertification, reaffirming the company’s long-standing commitment to quality, process control, and regulatory compliance in precision die-cutting and converting manufacturing. With these ISO 13485 and ISO 9001 certifications, PLITEK® continues to demonstrate its dedication to maintaining high quality manufacturing standards.
The ISO 13485:2016 certification highlights PLITEK®’s dedication to meeting stringent quality management system (QMS) requirements specific to medical device manufacturing. This internationally recognized standard ensures consistent quality, production and delivery of medical device components under strict regulatory control. PLITEK®’s ISO Class 8 cleanroom environments play a key role in supporting these quality standards, enabling the controlled manufacturing of converted and die cut components.
The ISO 9001:2015 certification further validates PLITEK®’s commitment to delivering high-quality products and services across a broad range of industries. As a globally recognized standard, ISO 9001:2015 provides a robust framework for effective quality management practices across all business operations.
These recertifications demonstrate PLITEK®’s ongoing investment in quality systems and its commitment to delivering consistent, innovative, and compliant manufacturing solutions to its customers.
With over 50 years of experience, PLITEK® is a vertically integrated manufacturer offering converting solutions — from engineering support and prototyping to ISO Class 8 cleanroom production and high-volume manufacturing. Leveraging advanced die-cutting technologies, material expertise, and scalable processes, PLITEK® supports customers across the medical, automotive, industrial, electronics, consumer, and other markets all while adhering to ISO 13485:2016 and ISO 9001:2015 certification standards.
About PLITEK® – Your ISO 13485 and ISO 9001 Certified Partner for Medical Converting
PLITEK® is a leading provider of medical die cutting, clean room manufacturing, and adhesive coating solutions, serving industries that demand high-performance materials, ISO-certified processes, clean room manufacturing and innovative converting capabilities.
With decades of expertise, we specialize in custom-engineered components for medical devices, wound care, ostomy, diagnostic strips, microfluidics, and wearable device medical applications. Our state-of-the-art facilities include ISO Class 8 clean rooms, ensuring strict contamination control for medical-grade materials and adhesives.
PLITEK®’s Medical Converting Capabilities Include:
- Medical Die Cutting – Rotary and flatbed die cutting for precision medical components.
- Class 8 Clean Room Film Extrusion – ISO-certified manufacturing for medical grade films and laminates.
- Adhesive Coating & Release Liners – Custom coating solutions for medical and other industries.
Our commitment to quality, precision, and innovation ensures that we deliver tailored solutions that meet the unique needs of our customers. Whether it’s custom-engineered die cut materials, adhesive-backed components, or advanced converting processes, PLITEK® provides the expertise and technology to drive success in manufacturing.