Anteo attaining ISO3485 certification is significant, it...

Anteo attaining ISO3485 certification is significant, it demonstrates that an expansion in capability is being pursued by Anteo. Every medical device regulator on the planet like USFDA, China FDA, TÜV SÜD and even our own little TGA require medical device ISO13485, to say its nothing more than ISO9001 is misleading. Any medical device Anteo design, regardless of who manufacturers it, needs to be managed in an ISO3485 controlled engineering system and so do whoever manufacturers the device. ISO9001 is not a barrier to entry to the medical device market and compliance with ISO3485 is. Its all about engineering quality and having ISO13485 means there is traceability in the quality of the engineering systems of the product to the final product.