Growth focused electronics manufacturing services (EMS) provider, ESCATEC, has achieved ISO 13485:2016 certification at its UK manufacturing facility, strengthening the Group’s ability to support medical device and healthcare OEMs with certified manufacturing across its global production network.
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 to EUK following a rigorous independent audit of its quality management systems, processes, and operational controls, confirming full compliance with the standard’s requirements.
“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 key strategic growth area for ESCATEC, supported by a multi-year investment programme to expand its capabilities and services to cater for it.
Albin notes that ESCATEC is making additional investments this year at EUK 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.
Established in 1984, ESCATEC is a global EMS provider headquartered in Penang, Malaysia, offering end-to-end services from design and development to mass manufacturing and after-sales support, across electronics, mechatronics, machining, MOEMS, box build, and plastic moulding.
The Group’s manufacturing footprint currently comprises four facilities in Malaysia, two in the Czech Republic, one each in the United Kingdom and Bulgaria, and a site for advanced electronics in Switzerland. It also operates a Design & Development (D&D) Centre in Switzerland and has strategic partnerships in Croatia and the United States.
To learn more, visit www.escatec.com.
