Regulatory Recap: Global Trends June 2019

International – Regulatory Recap: Global Trends June 2019

In our third global medical device regulatory update on global trends (November 2018 through May 2019), we share more updates on our previously identified...
Regulatory Recap: Global Trends June 2019

International – Regulatory Recap: Global Trends June 2019

In our third global medical device regulatory update on global trends (November 2018 through May 2019), we share more updates on our previously identified...
WHO Outlines Process to Designate Regulators as WHO-Listed Authorities

International – WHO Outlines Process to Designate Regulators as WHO-Listed Authorities

As part of a shift from the term “stringent regulatory authority” to “WHO-Listed Authority” (WLA), the World Health Organization (WHO) in May discussed some...
Regulating Software as a Medical Device in the age of Artificial Intelligence

International – Regulating Software as a Medical Device in the age of Artificial Intelligence

This article summarizes the current and proposed regulatory landscape for software as a medical device (SaMD) with artificial intelligence and machine learning capabilities. The...
10 of the Most Influential Companies in the Cardiovascular Space

International – 10 of the Most Influential Companies in the Cardiovascular Space

The cardiovascular space has been among the most exciting in medtech in recent years. A special panel at MD&M East, "Unmet Needs Straight from...
Taux de croissance de la production du marché des dispositifs médicaux connectés 2019-2025

International – Taux de croissance de la production du marché des dispositifs médicaux connectés...

Un rapport de recherche sur le « marché des dispositifs médicaux connectés » , établi par QYMarketStudy, présente une analyse concise des tendances les plus récentes du marché....
Saudi FDA regulatory update: MDR, UDI and Brexit

Saudi Arabia – Saudi FDA regulatory update: MDR, UDI and Brexit

The Saudi Food and Drug Authority (SFDA) has prepared adjustments to its medical device and IVD registration requirements in line with upcoming changes to...
GHTF final documents (updated)

International – GHTF final documents (updated)

These documents were created by the Global Harmonization Task force (GHTF). These are final documents and are still current... http://www.imdrf.org/documents/documents.asp#ghtf
IMDRF Documents (updated)

International – IMDRF Documents (updated)

This link contains final documents for IMDRF... http://www.imdrf.org/documents/documents.asp#imdrf   
WHO Outlines Process to Designate Regulators as WHO-Listed Authorities

International – WHO Guideline: recommendations on digital interventions for health system strengthening

The key aim of this guideline is to present recommendations based on a critical evaluation of the evidence on emerging digital health interventions that...

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