IDE Group commitment to Quality – ISO 13485 for our Dutch office
IDE has added its Rotterdam office to our ISO 13485 certification as part of its recent recertification audit by SGS.
IDE exists to build better futures for health. In fulfilling this purpose, IDE has grown to support clients in designing and manufacturing a diverse array of medical and in vitro diagnostic (IVD) technologies in Australia, Europe, and the USA. The regulations that govern these developed markets require sophisticated quality management systems to be in place at the organisations responsible for crucial processes involved in product development and realisation.
In 2012, IDE has chosen to implement a quality management system in compliance with the internationally recognised standard ISO 13485. The scope of this system has grown as IDE provides an extended set of services to clients of more sophisticated devices. IDE has embraced our QMS as a means of delivering additional commercial and performance benefits to our clients and our own business.
The inclusion of the Rotterdam office in our ISO 13485 certification scope shows the maturity of our European operation and our ambition to serve the European market with design, development and manufacturing services.
"At IDE, we are committed to develop a robust quality culture and to train our people in a responsible risk-based approach to compliance. We aspire to provide advice to clients that articulates the true value of quality in terms of efficacy, safety and brand reputation," says Nicolette Muller, Director for Quality and Capabilities.
"We are dedicated to continuous improvement of our quality management system and ensuring our processes remain agile and effective to support state-of-the-art development and manufacturing."
As part of the larger IDE vision, our QMS is a critical component in building better futures for health. The IDE QMS supports clients who have their own well-established systems and who want reliability and visibility. Still, we can also help newer clients who may not be able to implement a sophisticated QMS of their own. Consequently, our dedicated Quality Management team will continue to grow our QMS to support our expanding partnerships.
Do you have a vision of creating new medical technology to build better futures? Are you seeking an entrepreneurial partner who understands how to use quality systems scalably to drive better commercial outcomes? Contact IDE.
