The intended use of medical device software will dictate its regulatory path, and engineering teams should be aware of such ...

Already under the current MDD regime, medical devices, such as stand-alone MDSW, are classified according to their intended purpose and their inherent risks, and are divided into the following four ...

Many companies, particularly Software-as-a-Service (“SaaS”) and start-up companies, continue to struggle with the concept of export control classification of items with encryption functionality. This ...

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is warning device manufacturers that new regulations for software-based medical devices may have changed the classification of ...