Strategic Approaches to Global Regulatory Success: Intended Purpose and Indications for Use
Emergo by UL sponsored a session in the Exhibit Hall (Sept. 18) titled Navigating and Managing the Global Regulatory Landscape: Strategic Approaches for Success during RAPS 2024. This is part of a series on RAPS.
Improving Patient Engagement Through Gamification
Emergo by UL Human Factors Specialists discuss improving patient engagement through gamification.
Risk Analysis for Design and Innovation
Consider use-related risk analysis in simple terms, so that you can start early and use it as a powerful tool for creative output.
Preparing for Human Factors Engineering Meetings with US FDA Checklist
Emergo by UL human factors specialists share a checklist that is convenient when one is preparing for and participating in meetings with the U.S. FDA regarding human factors strategy.
UK Medical Device Regulator MHRA Announces Legislative Updates
MHRA, the UK medical device regulator, gave a progress report on the agency's work toward completing its roadmap of medical device legislation.
U.S. FDA Cites Two Medical Device Test Labs Regarding Data Quality and Integrity Concerns
U.S. regulator no longer accepting animal testing data from two Chinese labs to support premarket applications
Importer/Distributor MDR Requirements and Impacts for Manufacturers
In this on-demand webinar, our Emergo by UL expert shares insights on importer/distributor MDR requirements and impacts for manufacturers.
US FDA Updates Rules on VMSR Manufacturer’s Program
The U.S. FDA has finalized its 2022 draft guidance document Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.
EU Update: Current State of Medical Device Regulations
Returning from a long holiday and need to catch up on EU medical device and IVD regulatory developments? Read our update on European regulatory news over the last few months.
Human Factors Considerations for Medical Devices Used by Older Adults
This article explores the current landscape of how older adult users might interact with technology, particularly those in the healthcare space.