Blogs
Safety and Performance (SSP) of Class…
The Regulation (EU) 2017/745 on medical devices requires that the manufacturer shall draw up a summar…
ICH: Guideline on Testing for Carcino…
Over the course of drug development, it is important for sponsors to develop a scientifically robust …
Regulatory Changes for Software Based…
The Therapeutic Goods Administration (TGA) regulates software-based medical devices; including softwa…
Medical Devices – Regulatory Updates …
EUROPE
1.Guidance for industry on MHRA’s expectations for return to UK on-site inspections
In l…
SaMD Regulatory Landscape in the US a…
Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and …
Clinical and Performance Evaluation u…
Clinical evaluation of medical devices is a systematic and planned process that contributes to the co…
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