Quality Management System
Ximedica's proprietary Quality Management System ensures your products have a smooth passage through the development process and over all regulatory hurdles.
A fully qualified Quality Management System
In accordance with EN ISO 13485:2012, Ximedica’s QMS habitually demonstrates its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements. As an Approved Vendor of dozens of major Med Tech and Pharma companies, Ximedica’s QMS is successfully audited by our clients as well as by our Notified Body on a regular basis.
Committed to continuous improvement
Ximedica applied user-centric design research during the QMS development to create the most flexible yet appropriately rigorous Design Control process. Human factors engineers and information architects continuously work alongside our Quality and Regulatory personnel to further develop a QMS that marries the rigors of the FDA with lean development best practices. Our QMS was built to be flexible, efficient, effective and most important adaptive. We maintain a rigorous CAPA process to ensure continuous improvement of systems and procedures as measured by Quality Metrics.
Dedicated teams ensuring complete compliance
The Quality Services group is made up of four specific teams each with a specific role:
- Quality Systems – oversees quality adherence within all operating groups and maintains overarching quality processes
- Design Assurance – ensure that complete compliance to customer, quality and regulatory requirements is continuously in place in order to assure successful transfer of a design into manufacturing. They also are responsible for risk management activities and Design Verification and Design Validation activities.
- Quality Engineering – plans quality and supply control activities and provides support to manufacturing operations. They also oversee the QC inspection function for all stages of the manufacturing process.
- Document Control – manages the controlled documents related to products, development, manufacturing and the QMS.