2020 Amendments to IEC 62366 – Implications for Medical Device Usability Engineering
Examination of recent amendments to the IEC 62366 standard for medical device usability engineering and how manufacturers are impacted. Learn more at Emergo by UL's Human Factors Research & Design (HFR&D) unit.
Medical Device Usability Testing in China: Key Considerations for Manufacturers
New usability testing guidelines from China national medical products administration (NMPA) anticipated by late 2020. Learn more about China's medical device market and human factors engineering issues at Emergo by UL.
10 Steps to Conducting a Use-related Risk Analysis as Part of Your Human Factors Engineering Process
Use-related risk analysis (URRA) is a cornerstone activity for a thorough human factors engineering (HFE) process that meets the expectations set forth by US FDA and international reviewers.
US FDA 2020 Agenda Includes ISO 13485 Harmonization, De Novo Classification Scheme
The US Food and Drug Administration plans a final rule for De Novo medical device classification as well as a proposed rule for closer harmonization to ISO 13485:2016 quality management system requirements for later in 2020.
Request information from our specialists
Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.