Two Bulls/DEPT® | Althea SaMD Compliance
Health / Althea
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As a rapidly-growing, ASX-listed, global company, Althea needs to be a step ahead of the regulations that are about to hit the business. So in 2019, when talk about new regulations coming from Europe to Australia was getting serious, Althea knew they had to act fast. Althea and Two Bulls/DEPT®’s partnership reached back as far as 20xx and we were ready to roll, as we had already started implementing a certified quality management system for another client.
Our gap assessment - a thorough look at what’s missing in Althea’s documentation and procedures in order to fulfill the compliance requirements - identified all documentation needs. While there were no platform or software changes necessary, we’re now equipped to easily integrate the QMS process into any further development plans.
Both patients and clinicians trust lies at the core of Althea’s mission to help improve the lives of patients suffering from debilitating conditions. Being able to register the Althea Concierge platform as a medical device in the Australian Register of Therapeutic Goods gives additional assurance.
When looking at Althea’s internationally expanding business, the implemented QMS is making it much easier to move forward with new features, having the knowledge of QMS implementation and procedures in place.
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34 Oxford Street,
Collingwood, VIC 3066
Australia