Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch1-12.1-a: Essential principle 12.1(1) to (4): programmed devices and software as a medical device must be safe, reliable, accurate, usable, secure and repeatable for their purpose, fail safely, warn on lost services or degraded performance, protect data integrity and privacy, follow state-of-the-art development, suit their computing platforms and state their operating requirements

What does sch1-12.1-a require?

A programmed or programmable device, or software that is a device, that uses data or information must be designed and produced so that it is safe, performs, is dependable, accurate, precise, usable, secure and gives repeatable results to the degree its purpose demands; risks or impaired performance from fault conditions are removed or adequately reduced; it withstands interactions in use that could make it unsafe; and, where safety depends on it, it warns promptly when a service it relies on is disrupted or its performance suffers, lets the user check correct operation, keeps data integrity and quality, and keeps data private where relevant. Its development, production and upkeep must reflect current accepted practice in every engineering discipline that matters for software: the life cycle and the tools used to build it, versioning, quality and risk processes, security, testing (verification and validation), configuration and change control, and fixing defects; designed for the capability and configuration of the platforms it runs on; and supplied with the hardware, software, IT environment and security requirements needed to run it as intended.