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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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The medical device regulatory landscape is evolving. We help you bring safer products to markets worldwide and maintain compliance – even if your device is novel or high-risk.
Emergo by UL and its partner in China can support a successful device registration with expertise in CFDA clinical and testing requirements.
Emergo by UL offers KGMP quality system consulting for medical device companies selling in South Korea. We can help you comply with KGMP to register your medical device in Korea.
ISO 13485:2016 is coming! Let Emergo help you transition from ISO 13485:2003 or ISO 13485:2012. Local offices throughout the US, Canada, Europe and Asia.
ANSWERED ON THIS PAGE:
What does ISO 14971 require?
How do I implement ISO 14971?
How do I apply the risk management system and concepts to my product?
The latest industry insights from our global team.
Human factors specialists might opt to conduct an “out of the box” usability test of a medical device, such as for a home-use blood pressure monitor. In any case, it’s a great way to assess the user experience from the very start of product interactions.
Good user interface (UI) design ensures that users have a valuable and enjoyable experience when interacting with an application. For mobile apps related to healthcare, a UI that prioritizes the user is of utmost importance as these applications are developed with the goal of improving patients’ lives and the level of care they receive.
Overcome challenges associated with conducting human factors usability tests with multiple analysts by practicing effective notetaking and data collection.
As Emergo by UL reported in August, the Ministry of Health in Israel, Medical Device Division, AMAR, announced (August 14, 2023) proposed amendments to the medical device regulatory system.
This course takes someone who is already familiar with formative evaluation methods to the next level by addressing the nuances of conducting a formative evaluation.
Learn about designing effective instructions for medical products, including instructions that might take the form of instructions for use, quick reference guides, package inserts, online help and operator manuals.
Learn about a software user interface (UI) design process that is tailored to the development of medical products of various type.
Learn how to apply human factors engineering to medical products and the HFE process as it is prescribed by regulators and outlined in industry standards.
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