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Singapore UDI Phase – 1 Implementation

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The Health Sciences Authority of Singapore will implement the UDI system, a global system for tracking and identifying medical devices. The core components of Singapore’s UDI system are in accorda…

Automation: What Regulatory Team Needs to Know Before Investing

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In recent years, Automaton has become more powerful and its applications to business have increased dramatically. As a result, companies and business functions, including Regulatory, that hadn’t s…

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…
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