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Register for our webinar: South Korea Medical Device Registration
Medical device and IVD registration in South Korea
South Korea is one of the most promising medical device markets in Asia. The Ministry of Food and Drug Safety (MFDS) regulatory process is well
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Register for our webinar: Mapping UL 2900 Cybersecurity Standards to FDA Guidance
WATCH NOW: Mapping cybersecurity standards to FDA guidance
A set of standards published by UL to address medical device cybersecurity issues will soon be adopted by the US Food and Drug Administration to help
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Meeting FDA expectations for human factors engineering activities
Meeting FDA expectations for human factors engineering activities
Meeting FDA expectations for human factors engineering activities FDA has provided industry with guidance on how to apply human factors engineering (
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Impact of the FDA Premarket Guidance of Management of Cybersecurity in Medical Devices
It has been one year since the FDA released the latest Guidance Document pertaining to managing Cybersecurity in Medical Devices. What impact is this
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Register for our webinar: Getting 510(k) Clearance for Your Device from the US FDA
WATCH NOW: Getting 510(k) Device Clearance from the US FDA
The US remains the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one
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Wireless module medical device compliance webinar
Webinar: Wireless module compliance for medical devices: what you need to know
In our first wireless compliance webinar , we highlighted the two main pathways to medical device wireless compliance: modular approval and system
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Libary card - US FDA de novo webinar - May 2018
WATCH NOW: Understanding the US FDA De Novo Process for Novel Medical Devices
The US FDA medical device classification scheme presents some unique challenges for new technology. With a system based on equivalence ,
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Emergo webinar - wireless device requirements 2019
WATCH NOW: Navigating Regulatory Requirements for Wireless Medical Devices
Cellular technology adds exciting new possibilities for healthcare but can also bring regulatory burden. When you incorporate a wireless module into
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Human Factors Engineering for Medical Devices
Twenty years after FDA first called upon manufacturers to apply human factors engineering (HFE) in medical device development, HFE has become a
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