Homi Dalal

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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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