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Resource Library for Medical Device Professionals

3 total results. Show all resources.
Register for our webinar: Mapping UL 2900 Cybersecurity Standards to FDA Guidance
United States | Digital Health Products

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. In this one hour webinar, we discuss various aspects of medical device cybersecurity and how the new UL 2900 standards map to FDA guidance.

1 hour
Jul 12, 2017
Register for our webinar: Getting 510(k) Clearance for Your Device from the US FDA
United States

WATCH NOW: Getting 510(k) Device Clearance from the US FDA

The US is the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one hour webinar, we demystify the process and explain what you need to do before starting your 510(k) submission.

1 hour recording
May 22, 2017
Libary card - US FDA de novo webinar - May 2018
United States

WATCH NOW: Understanding the US FDA De Novo Process for Novel Medical Devices

In this one-hour webinar, we discuss the benefits and criteria of the FDA de novo process for novel medical devices.

1 hour
Apr 24, 2018