Software as a Medical Device (SaMD)

Electronic Medical Record

TGA guidance for SaMD Regulatory “Carve Out”

Following a public consultation on the Regulation of software, including Software as a Medical Device (SaMD) in early 2019, the TGA introduced several regulatory changes, including: new classification rules for...
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Software as a Medical Device – Upcoming Changes to the Australian Regulations

With advancements in software and medical device technology extending beyond the current scope of the Therapeutic Goods Regulations, new legislation is due to take effect in August 2020. Since the...
Software

EU Software Classification under MDR/IVDR – New Guidance Document

In October 2019 the Medical Device Coordination Group (MDCG) released a new guidance document on Qualification and Classification of Software in the European Regulations 2017/745 – MDR and 2017/746 –...

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