US FDA electronic Submission Template and Resource (eSTAR)
Watch our Emergo by UL subject matter expert as they outline the latest updates about US FDA electronic Submission Template and Resource (eSTAR).
Current Assessment of the MDR and IVDR: Mixed Results
European Commission survey shows increase in incomplete MDR, IVDR applications but also ample Notified Body capacity to take on clients
EU Market Regulations Update – How to Manage Expiring Notified Body Certificates
In this webinar, our Emergo by UL subject matter expert outlines the latest EU market regulatory updates.
Webinar debrief: Understanding International HFE Regulations for Medical Devices
Our Human Factors Research & Design (HFR&D) team can help you meet global human factors engineering (HFE) expectations, regulations, and standards for medical devices.
Tips for Designing Timeless Medical Device User Interfaces (UI)
Learn how to design an effective user interface (UI) for medical devices with these helpful tips.
Wiklund’s Perspective: The Value of User Research
Learn how user research bridges the design and human factors gaps and supports effective product development.
For Medical Devices in Europe Other than NLF, What Else is Applicable?
European chemical, environmental and other regulations beyond MDR and the New Legislative Framework applicable to medical devices
Mexican Regulators Update GMP COFEPRIS Requirements from NOM-241-SSA1-2021 and MDSAP
Medical device regulators in Mexico have updated Good Manufacturing Practices (GMP) COFEPRIS requirements from NOM-241-SSA-2021 and the Medical Device Single Audit Program (MDSAP).
Performance Evaluation – When, What and How to Prepare for EU IVDR (Presented in Portuguese)
Este webinar explica o conceito de Avaliação de Desempenho apresentado pelo IVDR 2017/746 e aspectos fundamentais a considerar para seu produto.
Global Regulatory Compliance for Medical Devices
Learn more about taking a strategic approach to achieve regulatory approval in medical device markets around the world.