Medical Device Manufacturing
ESCATEC Expands Medical Device Manufacturing Capacity
LUTTERWORTH, England — ESCATEC has achieved ISO 13485:2016 certification at its UK manufacturing facility, expanding the electronics manufacturing services provider’s ability to support medical device and healthcare OEMs across its global production network.
The certification allows customers to transfer and scale medical device production between ESCATEC facilities in Europe and Asia while maintaining consistent quality systems, traceability and regulatory compliance, the company said.
ISO 13485 is a quality management standard for medical device manufacturing. ESCATEC said the certification was granted after an independent audit of the UK facility’s 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,” said Charles-Alexandre Albin, CEO of ESCATEC. “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 for the company. The company is making additional investments at its 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.
ESCATEC is headquartered in Penang, Malaysia, and provides design, development, manufacturing and after-sales services for electronics, mechatronics, machining, micro-opto-electro-mechanical systems, box build and plastic molding.
The company’s manufacturing network includes four facilities in Malaysia, two in the Czech Republic, one in the United Kingdom, one in Bulgaria and an advanced electronics site in Switzerland. ESCATEC also operates a design and development center in Switzerland and has strategic partnerships in Croatia and the United States.
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