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What EU MDR changes mean to Manufacturers & what’s Next !

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With EU MDR timelines extended, some brief analysis for manufacturers: Devices benefitting The extension provisions apply to a device if: It was certified by a notified body under the Me…

Regulatory Managers Increase Flexibility without Losing Productivity

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The past two years have shown that teams desire greater flexibility and they’re willing to change jobs to get it. Flexibility has tremendous benefits for teams, including reduced burnout and great…

How Regulatory teams can Stop doing Low-Value work

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It’s actually a matter of professional life or death to get rid of your low-value work tasks that mean little or nothing to your end customers (patients) or colleagues. In the past, time manage…

Summary of new EU Clinical Trial Regulation

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The changes the regulation brings companies need to already be reviewing their current processes, systems and supporting infrastructure for clinical trial applications and operations. They need to…

China UDI Requirements

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Unique device identifier refers to a series of codes constituted of numbers, letters and/or symbols and established on the basis of standards. Unique device identifier, which includes product iden…