New TGA Regulations for Software as a Medical Device (SaMD)

Major changes are coming that will effect software development for medical devices, particularly apps.

Does your software developer have an ISO certification? If not this could have major repercussions for your digital healthcare products.

Two Bulls can identify requirements and implement required processes fast and efficiently.

The coming changes recognise the growing impact of SaMD in the health landscape, resulting in stricter classification of SaMD.

To comply, manufacturers of SaMD are expected to demonstrate their quality management processes and ensure best practice in everything they do. ISO13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.

🇺🇸 In the US, the FDA has been harmonizing its QSR with international quality systems standard ISO 13485:2016 since 2018 (see more below) and the release of a draft for the transition is expected this year.

🇦🇺 In Australia, the Therapeutic Goods (Medical Devices) Regulations were amended to clarify some existing requirements and to introduce new requirements for software-based medical devices. The changes have been put into effect on 25 February 2021. The TGA has released tools and guidelines to assist - see more below. 
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Two Bulls brings an impressive reputation for globally recognised digital products to healthcare. As a leading software development company with an ISO13485:2016 certificate, Two Bulls can support the development of a medical device as a Critical Supplier. We can provide clarity about what requirements your product needs to meet and implement existing processes fast and efficiently. Check out some case studies below.