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How Regulatory teams can Stop doing Low-Value work

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

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…

Regulatory Success Automation

You may think that regulatory automation is something that requires an intense technical infrastructure backed by a big budget to boot. But the truth is, even small businesses can use simple autom…

Medical Devices: Structured Content Authoring Saves Time & Reduces Cost

Medical device companies creating technical documentation, clinical / post-marketing reports, labeling and quality documentation with increasing regulations and recent MDR/IVDR compliance in mind …

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