ISO 13485

Interview with
Yann Laugier

Quality and Regulatory Affairs Director

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Behind the Scenes of Quality at Circle
Read the full interview with Yann Laugier, Circle's Quality Director, where he goes into more detail about our ISO 13485 certification and explains how it improves our products and services.
Yann Laugier
Quality Manager
Could you briefly define ISO 13485?
ISO 13485 is an international standard that defines the requirements for quality management systems in the medical device industry. This standard is intended for all types of organization, and is a must for companies wishing to market medical devices in Europe and Canada.
Obtaining this certification is a major step forward. How did our expertise in developing disruptive, innovative software solutions help you achieve this?
This BSI certification is a great collective achievement. Implementing ISO 'from scratch' is a challenge. From the outset of the project, ISO was seen as a goal for everyone. We were able to draw on rigorous working and software development methodologies that already existed at Circle. As a result, we were able to implement new processes fairly quickly, while ensuring that ISO was well accepted on a day-to-day basis. The various teams were very involved.
How does this certification reinforce Circle's reputation as a leader in the digital dentistry industry?
Compliance with ISO 13485 is a guarantee of quality and conformity for any medical device. This certification enables Circle to establish a multi-benefit approach. It not only guarantees the quality and efficiency of our processes, but also demonstrates the company's commitment to continuous improvement. This commitment strengthens the confidence of our customers, as it ensures the safety and reliability of our software products.
For dental companies looking for high-quality digital solutions, what convincing arguments can you put forward to explain why they should choose Circle, taking into account our ISO 13485 achievement and our commitment to excellence?
Choosing Circle means choosing an innovative solution built in compliance with the procedures required by ISO 13485. Healthcare professionals and end-users alike can have confidence in our software solution built to this standard, as it demonstrates our commitment to quality and safety. The application of ISO 13485 to our dental design solution provides a solid foundation for compliance, quality, safety and user satisfaction. It's essential in our business, and it's essential for Circle.
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