Software as Medical Device, India – Registration Requirements
Digital Health is fast emerging and is growing rapidly. New technologies such as telemedicines, Artificial Intelligence (AI) and Machine Learning (ML), Wearables for Glucose Monitoring, ECG etc are constantly evolving. Healthcare regulators across the world are devising regulations to help […]
Read MorePublic Consultation on a Medical Device Cybersecurity Labeling System
This article deals with the public consultation for the cybersecurity labeling scheme for medical devices. Medical equipment is increasingly being linked to hospital and home networks in order to improve patient care. However, this connectivity expands the attack surface for […]
Read MoreSoftware as Medical Device Update by TGA
The following article deals with the latest update for Software as Medical Device by The Australian TGA (Therapeutic Goods Administration). Software based Medical Devices (SaMD’s) are regulated by the TGA and must be included in the Australian Register of Therapeutic […]
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