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Emergo by UL's new human factors tool - provides training, tools, and resources.
Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.
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TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.
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Learn how to get FDA clearance for your medical device and navigate the approval process smoothly with our 510(k) flowchart.
This process chart explains Japan's medical device registration pathway for approval as defined and explained by Japan Medical Device Nomenclature (JMDN).
This process chart illustrates the TGA approval process per device classification in Australia and is available for download in the Regulatory Affairs Management Suite (RAMS).
Our China regulatory process chart offers intuitive, high-level overviews of your paths to product registration.
This guide helps explain how to prepare a Clinical Evaluation Report for medical devices as well as what required updates need to be made.
This chart highlights the CE marking certification process per medical device classification and is available in the Regulatory Affairs Management Suite (RAMS).
This chart shows the SFDA medical device approval process in Saudi Arabia and is free to download in the Regulatory Affairs Management Suite (RAMS).
This chart illustrates the MDA medical device approval process in Malaysia and is free to download in the Regulatory Affairs Management Suite (RAMS).
This chart illustrates the HSA medical device approval process in Singapore and is free to download in the Regulatory Affairs Management Suite (RAMS).
The first major revision to device regulations since 2007 has been released and the changes are significant. Smart companies are planning ahead to beat the crush of companies that will inevitably wait until the last minute.
This process chart illustrates the MOH approval process per device classification in Costa Rica and is available for download in the Regulatory Affairs Management Suite (RAMS).
Learn about South Korea's MFDS registration process per device classification, available for download in the Regulatory Affairs Management Suite (RAMS).
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