Japan PMDA Pre-Submission for Medical Devices
Learn more about how medical devices are authorized and the challenges foreign manufacturers face when seeking to register products in Japan.
Japan MHLW Ordinance 169 and Medical Device and IVD QMS Requirements
Find out how MO#169 and ISO 13485 vary and the audit processes for national, international and contract manufacturers entering Japan’s medical device market.
Negative Transfer During Autoinjector Use: Common Issues
Discover how transfer affects autoinjector users transitioning from syringes, pen-injectors, or emergency devices and learn strategies to address these challenges in product design for safer medication delivery.
Open Forum: Use-Related Risk Analysis Q&A
During this interactive session, our senior HFE experts answer pre-submitted and live questions about conducting and documenting use-related risk analyses of medical devices.
Hot Topics: Top 5 Human Factors Engineering-related Areas of Feedback from FDA
Emergo by UL human factors specialists discuss the most frequent topics among HFE-related feedback provided by the FDA.
UK’s Draft Post-market Surveillance (PMS) Requirements Compared to the EU Regulation Requirements on PMS
As noted in a previous Regulatory Update, a draft Post-Market Surveillance statutory instrument (PMS SI) was laid in Parliament (Oct. 21,) to introduce new PMS requirements.
Structural Revisions to European Medical Devices Regulation Proposed
You might have heard some rumors already: Several European parliamentarians sent a joint motion for resolution to the European Commission (EC). On October 21st, 2024, a European Parliament resolution “on the urgent need to revise the Medical Devices Regulation” (2024/2849(RSP)) was submitted to the EC.
MHRA Publishes Draft Post-Market Surveillance Requirements
The draft Post-Market Surveillance statutory instrument (PMS SI) was laid (Oct. 22,) in parliament.
Regulation (EU) 2024/1860 and IVDR Compliance in Europe
In this on-demand webinar, our Emergo by UL subject matter expert will share insights on Regulation (EU) 2024/1860 and IVDR transition periods in Europe.
New Technical Document to Facilitate Adverse Event Data Exchange
The International Medical Device Regulators Forum (IMDRF) published a new technical document from the Adverse Event Terminology Working Group (AET WG) this month Common Data Set for Adverse Event Data Exchange Between IMDRF Regulators, or in brief, N85.