Tag: Digital Health

Medical Devices – USA, Europe, Asia and ROW Regulatory News – May 2025

June 4, 2025
Medical Device

USA Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The aim of this guidance document is to outline the various mechanisms available...

Compliance, Digital Health, EU Regulations, FDA, Global Health, Healthcare Innovation, Med Tech, Medical Devices, Regulatory Affairs, UDI

MHRA Issues Transparency for Machine Learning and Medical Devices

October 16, 2024
Medical Device

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published guiding principles for machine learning medical devices, focusing on transparency. According to the MHRA guidance, “These...

AI, Device Performance, Digital Health, Healthcare Transparency, Innovation In Healthcare, Machine Learning, Medical Devices, MHRA, Regulatory Guidelines

Artificial Intelligence Based Regulatory Intelligence database

November 9, 2022
Digital Health

VISTAAR provides Global regulatory submission requirements, guidance documents, updates, news and other regulatory details to Biopharma, Medical Devices, Digital Health, Diagnostics, Consumer Health...

Artificial Intelligence, BioPharma, Consumer Health, Diagnostics, Digital Health, Medical Devices, OTC, Regulatory Intelligence

SaMD Regulatory Landscape in the US and Europe

August 13, 2021
Standards

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis...

compliant with good clinical practice, Digital Health, how the regulatory landscape is changing, Navigating a complex regulatory environment, Software as a Medical Device, the regulatory landscape for SaMD