Continuous Improvement and Quality Systems
The Natech systems include the ISO 13485 and ISO 9001 Quality Systems for ongoing, repeated processes. Additionally, Natech is an FDA registered medical device establishment.
Continual improvement only happens through the continual development of our employees and processes, which is why we continually grow our engineers and project teams using systems such as the Project Management System for one-time endeavors such as product development.
ISO 13485 Quality Management System for Medical Devices
Our customers produce life-critical devices and have confidence in the quality of the designs and manufactured product they receive from Natech. We achieve excellent quality by establishing quality processes from the beginning, and we support this with our in-depth employee training program. The team at Natech embraces scientific molding and scientific processing to qualify our injection molding and contract manufacturing processes during IQ/OQ/PQ.
ISO 9001 Quality Management System
Natech's team is focused on continual improvement. The ISO 9001 certification showcases our dedication to process improvement, quality, lean manufacturing and manufacturing excellence. Our team ensures that plastic parts and molds are maintained, regularly inspected and audited, and improvements are implemented on a consistent and routine basis.
FDA Registered Medical Device Establishment
In the summer of 2020, Natech received its FDA facility registration as a registered medical device establishment. This certification allows our engineers and team to provide high-quality medical devices to our clients. Additionally, clients have the peace of mind knowing that our quality and process controls are maintained at the highest standard.