How to Conduct a Known Problems Analysis (KPA) for NMPA Compliance
Emergo by UL Human Factors Specialists discuss the specific requirements the National Medical Products Association (NMPA) has set forth for known problems analyses.
Making the European Medical Device Nomenclature (EMDN) complete
Are you a medical device manufacturer doing business in Europe? Learn more about European Medical Device Nomenclature and why is it important for medical device manufacturers.
US FDA CDRH Warning Letters: A Review of 2024
Medical device manufacturers who want to better understand U.S. FDA warning letters should read our regulatory insight.
US FDA CDRH 2024 Annual Report Summary
Medical device manufacturers can read our summary of the 2024 Annual Report recently released by the U.S. FDA’s Center for Devices and Radiological Health.
US FDA Rules for Notification of Discontinuation or Meaningful Interruption in Manufacturing
The U.S. Food & Drug Administration has finalized guidance requiring manufacturers to notify it of discontinuations or meaningful interruptions in manufacturing for many devices during, or in advance of, a public health emergency.
Open Q&A forum: Maximizing Human Factors in Early Product Development
Our senior human factors engineering (HFE) and design experts answer questions about how to strategically approach discovery and design activities early on in product development.
MHRA Releases Suite of Guidance for New Post-Market Surveillance Regulation
The Medicines and Healthcare products Regulatory Agency (MHRA) announced the release of a suite of post-market surveillance (PMS) guidance (January 15).
Malaysia MDA Announces Agreement with China NMPA
This agreement paves the way for facilitating medical device market access for manufacturers between Malaysia and China.
Australian TGA Expands EU Transitional IVDR Arrangements for New Inclusion IVD Applications
Are you a manufacturer applying to register a medical device or IVD with the Australian Register of Therapeutic Goods (ARTG)? Now you have more options to fulfill the Manufacturer Evidence requirement to support an application.
Software
Emergo by UL offers digital applications, human factors engineering (HFE) platform, Optimal Product Usability Suite (OPUS) and Regulatory Affairs Management Suite, RAMS.