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Meeting FDA expectations for human factors engineering activities

Meeting FDA expectations for human factors engineering activities

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Developing Effective Training to Enhance and Support Internal HFE Resources

For years, medical device and pharmaceutical companies have faced a daunting task: to determine what human factors activities are required by regul
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The US remains the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one
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Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.