Tag: Medical Devices

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

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

March 11, 2025
Medical Device

USA Guidance on Institutional Review Board (IRB) Written Procedures The FDA and HHS OHRP have jointly issued the final guidance on Institutional Review Board (IRB) Written Procedures to enhance...

Asia Regulations, Europe Regulations, Global Regulatory, Healthcare Regulations, Med Tech Updates, Medical Device News, Medical Devices, Regulatory Updates, ROW Regulatory, USA Regulations

2024 Recap: Medical Device key Regulation/Guidance in USA, EU, Asia and ROW

December 16, 2024
Medical Device

USA EUROPE AUSTRALIA BRAZIL CANADA CHINA COLUMBIA CZECH-REPUBLIC FINLAND FRANCE GERMANY HONG-KONG HUNGARY ICELAND INDIA IRELAND ...

Asia, Device Compliance, EU, Global Health Healthcare Standards, Global Trends, Guidance, Health Tech, IVDR, MDR, Med Tech, Medical Device Regulations, Medical Devices, Medical Innovation, Regulations, Regulatory Compliance, Regulatory Updates, ROW, USA

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Oct 2024

November 6, 2024
Medical Device

USA Guidance on Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development The guidance provides a framework for determining whether, and what...

Asia Medical News, EU Regulations, Global Compliance, Healthcare Standards, Medical Device News, Medical Devices, Regulatory Updates, USA Medical Regulations

The Impact of AI on Medical Device Technology and Certification

October 16, 2024
Medical Device

Currently, AI refers to the ability of machines to perform cognitive tasks commonly associated with human intelligence including perception, learning, reasoning, planning, speech and language, and...

AI Algorithms, AI and Data, AI Impact, AI Med Tech, Data Science, Healthcare AI, Healthcare Innovation, Machine Learning, Medical Device Certification, Medical Devices

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