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Get the latest global medical device regulatory news, insights from our experts and more.
A look at the trend of how European legislation regarding medical devices and other products takes the form of regulations more so than directives
The European Medical Device Coordination Group (MDCG) calls for limiting applications of Article 97 MDR for legacy devices now that MDR transition periods have been extended.
The roles of the Blue Guide and New Legislative Framework in European medical device regulatory systems
A use-related risk analysis (URRA) is an important cornerstone activity in your human factors engineering (HFE) process that is expected by regulators.
Key human factors engineering and usability issues for makers of OTC hearing aid devices on the US market
Key considerations for conducting self-selection studies for medical devices
Medical device usability testing and the emergence of artificial intelligence
A look at key benefits of integrating HFE into medical device PMS processes
A look at the benefits of human factors engineering in consumer product design
The UK MHRA has extended timeframes for accepting CE Marked medical devices, and expects new legislation to roll out in mid-2025
Mexican regulators have updated Good Manufacturing Practice (GMP) and quality management system requirements for medical devices sold in the country.
US regulator targets possible discrepancies regarding Unique Device identification requirements
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