This client is seeking to find Victorian companies accredited with ISO 13485. The successful manufacturer must have cleanrooms dedicated to moulding and assembly of devices and components. The product is an implantable and therefore requires high levels of cleanliness, Class 7 or 8 cleanrooms for over-moulding of Polycarbonate and Silicone Rubber, through assembly and packaging processes. The Polycarbonate part of the device will be removed during surgery while the Silicone Rubber part will remain in the patient’s body for their entire life.
If this is of interest contact the client direct: Pascal Yee 0432 757 651 or engineer@ingeneus.com.au