Korea Medical Device GMP (K-GMP) Compliance and Challenges
In our second installment in a series, we discuss how the K-GMP certificate is an integral step to entering the market in South Korea.
Primer on South Korea’s Medical Device Regulatory System
In this first in a series of regulatory articles, we give an update on the medical device regulatory system in South Korea.
MHRA Update on Classification of Software as a Medical Device (SaMD)
MHRA confirmed they will adopt the risk categorization in IMDRF: "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations.
Global Medical Device Adverse Event Coding
Here we at Emergo by UL give an update on the current state of global adverse event coding.
U.S. FDA Pre-Submissions
In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights about U.S. FDA Pre-Submissions.
Update from MHRA on UK MedTech Regulatory Reform
The UK medical device regulator MHRA presented a webinar (March 5) on the upcoming changes to the medical devices legislation for Great Britain.
EU Update: Deadline Nears for In-house Devices to Comply with IVDR
This summarizes our In-house Devices per European IVDR Webinar and includes impending deadlines and questions posed during the session.
In-house Tests Under EU IVDR – How to Best Meet Your IVDR Deadlines
In this on-demand webinar, our Emergo by UL subject matter expert navigates through current regulatory requirements under IVDR.
FDA Sounds Alarm on Fraudulent Testing Data at Third-party Labs
The FDA reminds device manufacturers and medical device study sponsors to cautiously select third-party laboratories for verification and validation testing.
US FDA CDRH Warning Letters: A Review of 2023
Manufacturers can better understand quality and regulatory issues of concern by the U.S. Food and Drug Administration (FDA) by reviewing relevant warning letters. This can allow companies to focus on problem areas as they continually assess and improve their internal procedures and processes.