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Join Amanda Maxwell, Regulatory Affairs Editor, David Filmore, Executive Editor, and Ashley Yeo, Principal Analyst of MedTech Insight for a look at medical device (MDR) regulation and the key changes in the US and European medical device markets that are sure to change the industry worldwide in the months and years to come.
Topics covered include an overview of the US and EU medical device regulatory markets and the changes that will take place; the FDA’s shift in focus and how this powerful organization has made improvements in their efficiencies; real-world data and its uses; nascent regulatory mechanisms and key regulatory players; and howmedical device manufacturers must prepare in the face of future regulation of medical devices and IVDs.
The session closes with a discussion of the Dalli Plan of Joint Actions, and an insightful update on the UK and Brexit.
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Medtech Insight: global medical technology news & analysis
A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this first installment of a 10-part series, a procedure for hosting inspections is addressed.
Topics FDA
Medtech Insight: global medical technology news & analysis
By Marion Webb
Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.
Topics Digital Health FDA
Medtech Insight: global medical technology news & analysis
RTI Surgical, a surgical implants company, hired a global spine president and an original equipment manufacturer products president; Guerbet, a maker of medical-imaging products, promoted its chief commercial officer to CEO; and more.
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