Blogs
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…
Medical Devices-Regulatory Updates-As…
Malaysia (MDA)
1. Malaysia’s MDA updates guidelines for testing medical face masks
Malaysia’s M…
Medical Devices USA/Europe Regulatory…
EUROPE
1. First references of harmonised European standards in support of Regulation (EU) 2017/745…
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