Online Policies
Agreements governing your use of Emergobyul.com
Determining when to Utilize the Pre-Submissions Q-Submission (Pre-Sub) Process
Optimize your FDA Pre-Sub process and know when to use the Pre-Sub option for better regulatory outcomes.
European Commission Releases 2025 Work Program
A press release by the European Commission announced its 2025 Commission Work Program. The primary message: “Moving forward together: A Bolder, Simpler, Faster Union”.
EU Revises Guidance on Notified Bodies: Structured Dialogues and Leveraging Evidence
Medical device manufacturers doing business in the European Union (EU) will want to review the most recent version of the MDCG 2019-6 Questions and Answers (Q&A) document, which represents the most significant update to date regarding notified bodies.
EC Announces Pilot of Coordinated Assessment of Clinical Investigations and Performance Evaluation
The European Commission has announced a pilot program that may shorten the time to market for medical device manufacturers in Europe. The coordinated assessment procedure is a mechanism to permit a single application to multiple member states in which the Clinical Investigations and Performance Studies (CI/PS) would be conducted.
Sarah Mundim
U.S. FDA Medical Device Testing for Premarket Submissions
Gain insights into U.S. FDA regulatory classifications and testing requirements for introducing medical devices to the market, including high-risk devices.
IMDRF Releases Key Guidance Documents for Medical Device Software
The IMDRF has released two new key medical device software guidance documents.
Top pen-injector use errors and how to mitigate them
An Emergo by UL human factors specialist discusses the top use errors observed when evaluating pen-injector interactions during a usability study, and how manufacturers can work towards mitigating such use errors.
The Benefits of Running Pilot Tests for Usability Studies
Emergo by UL Human Factors Specialists discuss the benefits of running pilot tests prior to conducting usability studies.