Clinical Research

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Utilization of Least Burdensome Principles during FDA Reviews Benefits Industry

Published: May 16, 2022

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May 26, 2021: Marking a Regulatory Milestone for EU Medical Device Manufacturers

Published: May 25, 2021

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MDCG Issues Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)

Published: October 2, 2019

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Three Essentials for Smart IVD Clinical Trial Design

Published: June 4, 2019

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Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings

Published: January 23, 2018

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The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy

Published: August 30, 2017

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Why Regional Reimbursement Strategies Could Be Right For Medtech

Published: March 30, 2017

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