South Korea Regulator Accepts MDSAP Certificates Eliminating On-Site K-GMP Audits
In our third article in a series, we take a look at how manufacturers can submit MDSAP Certificates in Place of on-site K-GMP audits.
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.
Using Desk-based Readability Assessments to Evaluate the Labeling of Medical Devices
Desk-based readability assessments are a time and resource-effective method of evaluating the readability of your labeling, including your instructions for use (IFU), quick reference guide (QRG) or other user-facing documents (e.g. patient information leaflets). In this article, Emergo by UL discusses the applications of readability assessments and presents an overview of three methods.
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.