FDA Draft Guidance on Predetermined Change Control Plans: Implications for Medical Device Manufacturers
Conducting an Aseptic Presentation Study
FDA Guidance on the Q-Submission Program
A Summary of Risk Management Tools for Human Factors
FYI, Most Medical Devices Are Not Designed For Most People
Gender Inclusivity in User Research
Summary of MedTech Intelligence’s Webinar from Nov 30th, 2021
FDA Final Rule on the Use of Symbols in Labeling
Telehealth During and After Covid-19
Beyond the 5 Why’s
4 Examples of How COVID is Accelerating Home Use Devices
Be Careful What You Ask For: Nuances of Phrasing Research Questions
Updates from the FDA CDRH Human Factors Team 2019
Worst-Case Scenarios for Usability Testing
Simulating Stress in Usability Testing
Update on Hospital Access Challenges
Seeking Proposals: 2018 HFES Healthcare Symposium in Boston
Hospital Access Challenges: Panel Report
FDA/CDER Workshop Highlights
FDA Draft Guidance - Comparative Use HF Studies in an ANDA