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Escatec – now FDA registered for medical devices

Escatec Medical Sdn Bhd, part of the Escatec Group based in Penang, is now FDA registered as a Medical Device Contract Manufacturer.
Markus Walther, Escatec's CEO, said, "Quality, safety and traceability are vital for medical devices. The Escatec Group is renowned for its quality and precision, which is why companies come to us for innovative solutions to design challenges and quality manufacture that they can trust to put their brand on. FDA registration for the manufacturing of medical devices is mandatory for products that are marketed in the USA and is globally recognised as a sign of manufacturing excellence and quality, opening up the world market for our customers."

The FDA registration implies that Escatec Medical Sdn Bhd has necessary management, production and process controls for ensuring that products produced meet the necessary safety and quality requirements for the US medical device market.
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January 17 2019 2:20 pm V11.11.0-2