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![UK MHRA Guidance: Software and AI as a Medical Device](https://static.wixstatic.com/media/6516fb_58b95b021a264084a617292e944b081a~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_58b95b021a264084a617292e944b081a~mv2.webp)
Sharan Murugan
3 days ago2 min read
UK MHRA Guidance: Software and AI as a Medical Device
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â updated its guidance on Software and Artificial Intelligence (AI) as a...
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![Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices](https://static.wixstatic.com/media/nsplsh_1e6e7329cf914e4d86da1a80d81f5ba8~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_1e6e7329cf914e4d86da1a80d81f5ba8~mv2.webp)
Sharan Murugan
Jul 29, 20242 min read
Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices
Australia's Therapeutic Goods Administration (TGA) provided comprehensive guidance on "Essential Principle 13B", which pertains to the...
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![TGA Guidance: Regulatory Changes for Software-Based Medical Devices](https://static.wixstatic.com/media/6516fb_13da3b3d88ba497c8c10cbeed4ea1269~mv2.png/v1/fill/w_399,h_243,fp_0.50_0.50,q_95,enc_auto/6516fb_13da3b3d88ba497c8c10cbeed4ea1269~mv2.webp)
Sharan Murugan
Jul 6, 20242 min read
TGA Guidance: Regulatory Changes for Software-Based Medical Devices
The Therapeutic Goods Administration (TGA) has released updated guidance (03 July, 2024) "Regulatory Changes for Software-Based Medical...
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![Australia TGA: Regulation of Software based Medical Devices](https://static.wixstatic.com/media/6516fb_fbe277c8669e4642ae40446622de465e~mv2.png/v1/fill/w_399,h_300,fp_0.50_0.50,q_95,enc_auto/6516fb_fbe277c8669e4642ae40446622de465e~mv2.webp)
Sharan Murugan
May 14, 20242 min read
Australia TGA: Regulation of Software based Medical Devices
On 9th May 2023 Australia's Therapeutic Goods Administration (TGA) released an updated "Regulation of Software-based Medical Devices"...
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![UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device](https://static.wixstatic.com/media/nsplsh_e75c298a94764892bc13f014d6ff0676~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_e75c298a94764892bc13f014d6ff0676~mv2.webp)
Sharan Murugan
May 6, 20242 min read
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
Last Friday (03 May 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Software and...
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![Australia's TGA: Guidance on Regulation of Software based Medical Devices](https://static.wixstatic.com/media/nsplsh_34334c7776432d6551504d~mv2_d_5248_3936_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_34334c7776432d6551504d~mv2_d_5248_3936_s_4_2.webp)
Sharan Murugan
Jun 4, 20231 min read
Australia's TGA: Guidance on Regulation of Software based Medical Devices
Recently on 2nd June, 2023 Australia's Therapeutic Goods Administration (TGA) released guidance on the "Regulation of Software based...
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![UK MHRA: MD Guidance on Crafting an Intended Purpose in the Context of SaMD](https://static.wixstatic.com/media/6516fb_1846ed6517d94025a3ff6863488560f1~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_1846ed6517d94025a3ff6863488560f1~mv2.webp)
Sharan Murugan
Mar 22, 20231 min read
UK MHRA: MD Guidance on Crafting an Intended Purpose in the Context of SaMD
Earlier today (22 March 2023) UK Medicines and Healthcare products Regulatory Agency released updated guidance on "Crafting an intended...
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