Quality Medical Device Development

A passion for quality is critical part of what makes Cirtec a leading contract manufacturer for the nation’s top medical device companies. Cirtec’s thorough approach to quality includes proactive quality assurance initiatives and the ongoing review of every aspect of our business. Thorough quality audits ensure that our systems are continually improved and updated to conform to the latest standards and regulations.

Cirtec’s focus on quality is also reflected in robust training programs, which require that every Cirtec employee be trained to all applicable quality procedures and relevant SOPs. Our commitment is to deliver the highest quality medical device development processes and services in the world.

Quality and compliance are critical elements of medical device performance, and critical to our customers meeting their technical and financial goals. Our internal quality structures and audits enable us to provide our clients the timely and cost effective measures that they demand, and combined with our expertise in medical device technology, enable us to deliver innovative medical device solutions of the highest possible quality.

Cirtec Quality Policy

Cirtec is committed to meeting our customers’ needs by providing exceptional service in the development and manufacturing of the highest quality medical devices. Each employee is dedicated to continuously improving our quality management system and complying with all regulatory requirements.

We have the following quality certifications:

ISO 13485:2003 – LG

ISO 9001:2008 – ELM

ISO 13485:2003 – ELM