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    Medical Device Regulatory Update: Usability, UDI and RoHS

    What do human factors engineering (HFE), unique device identifiers (UDIs) and restriction of hazardous substances (RoHS) have in common? More than one may think. At the recent 2014 RAPS San Francisco Bay Area Chapter’s annual educational collaboration with the ASQ Northern California Biomedical Division, attendees gathered to enhance their understanding of HFE, the requirements for UDI and the impact of the RoHS 2 Directive 2011/65/EU 1 aimed at devices currently under D...
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    Embracing Change in EU Medical Device Regulation: The Notified Body Perspective

    The RAPS San Francisco Bay Area Chapter kicked off 2014 with a 7 March conference focused on the proposed EU medical device regulations. Topics covered both near-term and long-term changes in key requirements critical to demonstrating compliance to existing directives and impending changes as proposed. The message was clear-change is underway in the EU and the medical device industry needs to be ready sooner than anticipated. A BSI Healthcare medical device expert team p...