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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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This process chart illustrates the INVIMA approval process per device classification in Colombia and is available for download in the Regulatory Affairs Management Suite (RAMS).
In this free webinar, you’ll gain insights from Emergo’s medical device clinical research team on the role of PMCF studies in MDR compliance and what it takes to conduct a PMCF study that should be acceptable to all stakeholders.
This process chart illustrates the MDD approval process per device classification in Hong Kong and is available for download in the Regulatory Affairs Management Suite (RAMS).
COFEPRIS regulatory approval process chart per device classification in Mexico is available for download in our Regulatory Affairs Management Suite (RAMS).
The UK's withdrawal from the European Union has major ramifications for medical device manufacturers, including in-country representation requirements for companies selling their devices in Great Britain.
This process chart shows Brazil's medical device regulatory approval process and is free to download in the Regulatory Affairs Management Suite (RAMS).
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
As medical devices adopt more advanced technologies, their reliance on software has been increasing.
The transition period from MDD to MDR comes to an end on May 26th, 2021. Among the many regulatory changes, the role of human factors is greatly enhanced.
FDA outlines its fundamental expectations for applying human factors engineering (HFE) to combination products in its published guidance documents.
This webinar is intended to highlight some of the key areas where the standard was changed technically, and where guidance was either introduced or expanded.
Many companies will need to maintain more robust PMS procedures and perform more PMCF studies to meet their Notified Body’s expectations. In this free webinar, we will discuss new European PMS and PMCF requirements.
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