lowendahl.eu - News and information

lowendahl.eu - News and information

FDA plan to introduce ISO 13485 this fall

FDA/USA relatedPosted by Peter Feb 27, 2019 18:54:05
That FDA plan to change the QSR to follow ISO 13485 has been know for a while. The plan is to introduce this in the fall 2019. In a presentation made in December 2018 FDA points out that it will be a transition period partly because they need to trainbthe personnel but also that they need to revise the QSIT inspection handbook

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