Medical devices and medical equipment are subject to the approval of federal authorities prior to production and distribution, and in most cases it is required that products submitted for approval are manufactured, assembled and packed in a clean room facility.
Our planned clean room facilities meet ISO 14644-1 CLASS ISO 8 (Equivalent to FED STD 209E – Class 100,000) where we produce small size products. Our clean room service includes assembly, final processing such as inserts insertion and packaging.
