Wieson Taiwan Manufacturing Plant is now certified for ISO13485:2016 – an internationally recognized standard set of requirements issued.
As background: The certification focuses on risk management and design control during product development, specific requirements for inspection and traceability for medical devices, and for verification of the effectiveness of corrective and preventative actions.
From now on, Wieson Technologies (Dong Guan) Co., LTD. and Taiwan Manufacturing Plant both have ISO13485 certification.
The scope is about the manufacture of connectors, cables and RF (Radio Frequency) assembly for medical use.
Holding the ISO13485 certification helps the customer’s product, which need to comply with regulations for medical device.