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This chart illustrates the DMEC approval process for medical devices in Vietnam and is available for download in the Regulatory Affairs Management Suite (RAMS).
The Thai FDA medical device approval process explained: This process chart illustrates the approval process for medical devices in Thailand and is available for download in the Regulatory Affairs Management Suite (RAMS).
Learn how to approach early research and design to quickly build a strong foundation of usability for new development efforts.
Learn more on how to conduct a biological evaluation ISO 10993-1.
Learn more about EU In Vitro Diagnostic Medical Device Regulations.
Learn more about tips and other information to help you feel comfortable when corresponding with the FDA.
Expectations among regulatory bodies are growing just as HFE methods become more and more complex. How will you meet the requirements involved with marketing a medical device?
In this webinar, our Emergo by UL subject matter expert outlines the latest updates on medical device regulatory requirements in South Korea.
Learn about the FDA’s expectations for knowledge tasks and how to plan for and conduct knowledge tasks during usability testing.
In this webinar, our Emergo by UL expert outlines the latest updates on regulatory requirements in Japan.
Este webinar explica o conceito de Avaliação de Desempenho apresentado pelo IVDR 2017/746 e aspectos fundamentais a considerar para seu produto.
Learn how to improve feedback and reduce the nervousness in participants during medical device user research studies.
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