Continuous Improvement Driven by Quality Systems
At Natech, we are committed to delivering high-quality products and services to our customers. To ensure this, we adhere to strict, internationally recognized quality standards such as the ISO 13485 and ISO 9001 Quality Systems. These certifications are essential for ongoing, repeated processes, and they drive us to achieve excellent quality by establishing quality processes from the beginning. Moreover, we have an in-depth employee training program that helps us continually develop our employees and processes.
Continual improvement only happens through the continual development of our employees and processes, which is why we continually grow our engineers and project teams.
ISO 13485: 2016 Quality Management System Certifications for Medical Devices
As a medical device manufacturer, we understand the importance of delivering life-critical devices to our customers. That’s why we have obtained the ISO 13485 Quality Management System certification for medical devices. This certification ensures that our injection molding and contract manufacturing processes are of the highest quality. Our team embraces scientific molding and scientific processing, which allows us to qualify our processes during IQ/OQ/PQ.
ISO 9001:2015 Quality Management System Certifications
In addition to the ISO 13485 certification, we have also obtained the ISO 9001 Quality Management System certification, which showcases our dedication to process improvement, quality, lean manufacturing, and manufacturing excellence. We maintain and regularly inspect our plastic parts and molds, and we continually implement improvements to ensure that our customers receive the best quality products.
FDA Registered Medical Device Establishment
We are proud to have received our FDA facility registration as a registered medical device establishment in the summer of 2020. This certification allows us to provide high-quality medical devices to our clients, and it ensures that our quality and process controls are maintained at the highest standard. Our customers can have peace of mind knowing that we adhere to the strictest quality standards to deliver the best products and services.
