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In this week’s Medtech Insight podcast, senior reporter Elizabeth Orr gives the skinny on the latest developments surrounding the National Evaluation System for health Technology Coordinating Center, or NESTcc.
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The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.