US FDA Moves to Electronic Formats for Medical Device Export Documents
FDA now issues export certificates and documents electronically for medical device manufacturers and other stakeholders
Brazil ANVISA Announces a Revised IVD Regulation RDC 830/2023
Updates to the regulation include alignment with administrative provisions from the RDC 751/2022 on medical devices and some hints on what to expect next.
The 2023 Medical Device Regulatory Year in Review
We take a look back at some of the most significant medical device and IVD regulatory and compliance developments of 2023.
Integrated Risk Management Throughout Device Lifecycle
In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights about integrated risk management.
Integrating User Interface Design Validation into Human Factors Studies
Learn best practices for integrating UI design validation into HF validation tests to support a smooth and productive endeavor.
Conducting a Threshold Analysis to Meet FDA Expectations
Threshold Analysis and FDA Expectations | Emergo by UL
FDA Announces Intent to Classify Certain Solid Wound Dressings
On November 30, 2023, the FDA announced in the Federal Register its intention to classify certain types of wound dressings that had remained unclassified as pre-amendment devices; i.e., devices that were in commercial distribution before enactment of the Medical Device Amendments of May 28, 1976.
EU MDR Update: Significant changes to FAQ on clinical investigations
EU medical device makers and clinical investigation sponsors should review updated FAQs from MDCG regarding significant changes to the clinical investigations section of MDR 2017/745.
EU MDR PMS Including PMCF and Vigilance
In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights about EU MDR PMS, including PMCF and vigilance.
EU Compliance, Strategies and Goals for MDR and IVDR
Emergo by UL professionals gave an update on EU Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostic Devices Regulation (IVDR, 2017/746) compliance.