Malaysia-headquartered electronics manufacturing services provider ESCATEC has achieved ISO 13485:2016 certification at its manufacturing facility in Lutterworth, England, expanding its capacity to support medical device and healthcare OEMs across its global production network. The certification has direct implications for OEMs seeking a contract manufacturing partner capable of maintaining consistent quality standards across multiple international sites.

As reported by Assembly, the certification was granted following an independent audit of the UK facility's quality management systems, processes and operational controls. It allows customers to transfer and scale medical device production between ESCATEC's facilities in Europe and Asia while maintaining traceability and regulatory compliance throughout the supply chain.

ISO 13485 is the internationally recognised quality management standard for the design and manufacture of medical devices. Achieving certification requires demonstration that a facility's systems consistently meet the regulatory and customer requirements applicable to medical devices and related services.

Charles-Alexandre Albin, CEO of ESCATEC, said: "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."

ESCATEC said the medical device sector is a strategic growth area. In addition to the certification, the company is making further investments at the UK facility this year, including a new SMT line to increase capacity and throughput and a dedicated medical-grade cleanroom to meet contamination and environmental requirements for regulated production environments.

ESCATEC is headquartered in Penang, Malaysia, and provides design, development, manufacturing and after-sales services covering electronics, mechatronics, machining, micro-opto-electro-mechanical systems, box build and plastic moulding. Its manufacturing network spans four facilities in Malaysia, two in the Czech Republic, one in the UK, one in Bulgaria and an advanced electronics site in Switzerland. The company also operates a design and development centre in Switzerland and holds strategic partnerships in Croatia and the United States.

The Lutterworth facility's ISO 13485 certification brings the UK site into alignment with ESCATEC's existing certified facilities, enabling seamless programme transfers and multi-site production strategies for customers with complex regulatory and volume requirements.