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Sharan Murugan
- Jun 17, 2023
- 1 min
USFDA Guidance: Content of Premarket Submissions for Device Software Functions
Last Wednesday (14 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for...
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Sharan Murugan
- Jun 6, 2023
- 1 min
Philippines FDA: Guidelines on the Application for License to Operate
Yesterday (6 June 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines on the...
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Sharan Murugan
- Jun 4, 2023
- 1 min
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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Sharan Murugan
- Jun 4, 2023
- 1 min
USFDA Guidance: Medical Device Submissions "The Q-Submission Program"
Last Friday (02 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health and Center for...
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Sharan Murugan
- May 28, 2023
- 2 min
Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (26 May 2023) the "Guidance document...
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