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Medical Devices – USA/Europe Regulato…

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EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedu…
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Authorization of Medical Devices base…

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The fast evolution of medical technology and the essential role of medical devices in the health care…
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Safety and Performance (SSP) of Class…

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The Regulation (EU) 2017/745 on medical devices requires that the manufacturer shall draw up a summar…
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ICH: Guideline on Testing for Carcino…

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Over the course of drug development, it is important for sponsors to develop a scientifically robust …
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Regulatory Changes for Software Based…

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The Therapeutic Goods Administration (TGA) regulates software-based medical devices; including softwa…
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Medical Devices – Regulatory Updates …

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EUROPE 1.Guidance for industry on MHRA’s expectations for return to UK on-site inspections In l…
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