Homi Dalal

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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TGA deploys Post Market Review Compliance Dashboard

Under the Therapeutic Goods Act 1989, it is mandatory for sponsors and manufacturers to report adverse events that have, or could have, led to death, serious illness or injury to...
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TGA published review of safety and performance issues in Medical Device software

Software as a Medical Device (SaMD) In recent years software usage has become ubiquitous and software resources, particularly mobile apps accessible through smartphones, have increased in complexity and usage. The...
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Risk Management ISO Standards – ISO 14971: 2019 and ISO TR 24971: 2019.

The definitive risk management standard for medical devices - ISO 14971: 2019 - Medical Devices – Application of Risk Management and the accompanying guidance on its application - ISO TR...

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