The certification enables customers to transfer and scale medical device production between ESCATEC sites in Europe and Asia while maintaining consistent quality systems, traceability, and regulatory compliance.
ISO 13485 is the globally recognised benchmark for medical device manufacturing, covering the full product lifecycle under strict regulatory and safety requirements. The certification was granted following a rigorous independent audit of quality management systems, processes, and operational controls.
“Achieving ISO 13485 in the UK is a key milestone for ESCATEC and means our customers can expect the same high standards of quality, control, and traceability throughout our manufacturing network. This is particularly important for OEMs looking to scale production internationally without compromising quality,” said CEO Charles-Alexandre Albin.
The medical devices sector is a strategic growth area for ESCATEC, and the company is supporting this focus with a multi-year investment program to expand its capabilities and services for customers in the sector.
Albin pointed out that that ESCATEC is making additional investments in the UK this year to further enhance its ability to support medical-related projects, including a new SMT line to increase capacity and throughput, and a dedicated medical-grade cleanroom to meet stringent contamination and environmental requirements.
