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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 accordan…
Automation: What RegulatoryTeam 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 se…
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 t…
Summary of new EU Clinical Trail 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 …
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