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New Directions Behavioral Health  Form

New Directions Behavioral Health Form

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Instructions and help about New Directions Behavioral Health

safety update report that needs to put be put into your technical documentation like I said at least annually and that will be reviewed very carefully by the notified bodies now um again if something comes out of vigilance you know it might be reportable events so you've got to report it into your competent authorities um within all of the markets that you you might place your device on under MDR in the EU you need to report into those um competent authorities and that that are defined time scales for reporting on depending on seriousness of the situation um when all of this comes out like I said before you've got to look go back and and as a team um review your risk assessment and then may it may may lead to other actions being taken like redesign a device and and other things all of this needs to be documented all of it needs to be um Justified with good rationale and and all of this documentation that

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