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Regularly Experts, Amanda Maxwell and Dave Filmore talk to Ashley Yeo about future key developments in the EU and US IVD regularly changes.
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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