ESCATEC secures ISO 13485 certification for UK facility
EMS provider ESCATEC has achieved ISO 13485:2016 certification at its manufacturing facility in Lutterworth, UK, enabling customers to transfer and scale medical device production across the company's global network while maintaining consistent quality and regulatory compliance.
ISO 13485 is the internationally recognised standard for medical device manufacturing, covering the full product lifecycle under strict regulatory and safety requirements. The certification was granted following an independent audit of ESCATEC's quality management systems, processes and operational controls at the UK site, according to a press release from the company.
The certification allows customers to move medical device production between ESCATEC's European and Asian facilities without compromising traceability or compliance – a consideration that is increasingly important for OEMs looking to scale internationally.
“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.
Alongside the certification, ESCATEC is making additional investments at the UK facility this year, including a new SMT line to increase capacity and a dedicated medical-grade cleanroom.
ESCATEC is headquartered in Penang, Malaysia, and the group operates nine manufacturing sites across Malaysia, the Czech Republic, the UK, Bulgaria and Switzerland, with a design and development centre in Switzerland and strategic partnerships in Croatia and the United States.
