Article 16(4) MDR & IVDR Certification: What Medical Device Manufacturers Need to Know
Medical device importers, distributors and others who modify medical devices for sale in the European Union should understand new requirements set by Article 16(4) of the European Union MDR and IVDR certification schemes.
US FDA Warning Letters: Considerations for LDTs including Timelines
Reviewing relevant U.S. Food and Drug Administration (FDA) warning letters can help manufacturers better understand areas of frequent concern related to quality management systems (QMS) and regulatory affairs. This allows companies to focus on areas of highest risk.
CMEF 2025
Schedule a meeting to learn more about how we can support you in getting to market faster.
EU AIA and its Interplay with the EU MDR/IVDR
Know how the EU Artificial Intelligence Act redefines the regulatory environment for AI-driven medical devices and IVDs.
Insights and expertise gained from a year of applying the 2024 HF guidance
Gain a deeper understanding of how to interpret and meet NMPA’s HF expectations.
Understanding Japan’s Clinical Data Requirements
The PMDA determines if clinical data is required for a medical device premarket authorization in Japan depending on the manufacturer’s non-clinical data and equivalence with like devices.
Health Canada Continues to Actively Monitor Supply of Medical Devices
The Canadian medical device regulator Health Canada continues to add and remove devices deemed in short supply.
IMDRF Updates Terminologies for Categorized Adverse Event Reporting
The technical document that defines the categories for adverse event reporting for medical devices has been updated by the IMDRF.
Webinar Debrief: Developing HFE Strategies to Meet Global Regulations
Debriefing on a recent webinar, Emergo by UL Senior Research Directors share global considerations for cornerstone HFE activities.
MHRA Publishes the Consultation Outcome on Statutory Fees
From August 29, 2024, to October 24, 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) held a public consultation on its proposed amendments to the statutory fees. The consultation reflected fees for services related to medicines, medical devices and blood components for transfusion in the UK