Obtaining ISO 13485 certification is not an end in itself - it's the marker of a profound organizational transformation. This international standard for quality management systems (QMS) in the field of medical devices influences every aspect of our operations. At Pixacare, integrating the standard's requirements required not only a change in our processes, but also a positive change in our corporate culture.
Compliance with ISO 13485 has led to a standardization of our production process for our medical device software. User requirements and associated technical specifications are now detailed in the technical file, providing a clear view of thearchitecture of each feature.
This translates into increased rigor in testing: unit tests, integration tests and functional tests. Engineers test code at various levels to verify its integrity. The result? Improved application performance and quality, with a significant reduction in bugs.
As part of our ISO 13485 compliance, all our marketing and sales documents must now be validated by our quality assurance manager. This additional step guarantees the precision andaccuracy of all the information we distribute. It also ensures full traceability of all documents, reinforcing our commitment to providing up-to-date, accurate information.
ISO 13485 certification has reinforced our commitment to customer satisfaction. All user complaints and feedback are now documented. We strive to provide the fastest and most effective response possible to every problem.
What's more, we follow an analysis method to determine the origin of any malfunctions encountered. These are communicated to our technical team.
If a problem arises, our aim is to resolve it as quickly as possible, while ensuring that it doesn't happen again. This approach has fostered a virtuous circle between the product development team and customer support.
The integration of ISO 13485 requirements at Pixacare has gone beyond the scope of improving our medical devices. It's a global change that impacts every department and every facet of our business. Every member of the Pixacare team is committed to meeting the requirements dictated by the standard, a commitment that is reflected in our end product: a high-quality, high-performance and safe medical application.
Dr Hichem Bouchenaki, Quality Assurance and Regulatory Affairs Manager at Pixacare.
