Quality
Quality is not just a requirement, but a core principle embedded in how we work. Our device platforms and manufacturing processes are built to meet the highest international standards, supporting regulatory submissions for clinical supply and commercial launch for global markets.
Suitable, adequate and effective quality systems
Our quality management system supports global regulatory expectations and is designed to ensure patient safety, product performance, and consistency throughout the development, production and post-production phase of each device. It complies with ISO 13485:2016, EU Medical Device Regulation (MDR (EU) 2017/745), MDSAP (AU, BR, CA, JP and US) and 21 CFR 820, as documented with the respective QMS certificates.
Qualification and validation
Manufacturing takes place under controlled conditions. Equipment and infrastructure are qualified, processes are validated, and the majority of manufacturing occurs with automated processes. From incoming inspection, through injection molding, assembly, final inspection and documentation, every step is executed with a focus on repeatability and compliance.
Device traceability
Full product traceability is built into our production systems. From raw materials to final assembly, every device can be tracked by material ID and production batch number, providing the data required for regulatory submission, root cause analysis, or customer-specific documentation.
Audit-ready operations
We are audited over 50 times per year by leading global pharmaceutical companies, notified bodies, and regulatory authorities. These audits validate our systems, reinforce compliance, and ensure we are prepared to meet the expectations of even the most demanding partners.
View all of our quality certificates here.
