Transcription of Vigilance Reporting - BSI Group
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Copyright 2015 BSI. All rights reserved. Vigilance Reporting Vicky Medley - Head of QMS, Medical Devices November 2015 2 Copyright 2015 BSI. All rights reserved. 3 Copyright 2015 BSI. All rights reserved. Why? 4 Copyright 2015 BSI. All rights reserved.. protecting and improving public 5 Copyright 2015 BSI. All rights reserved. Protecting and promoting your health 6 Copyright 2015 BSI. All rights reserved.. undertakes a role of protecting people and their lives not only in the present but for the future.
Must Report - Trends . If a significant increase or trend of events or incidents that are usually excluded from individual reporting . The manufacturer should have suitable systems in place for proactive scrutiny of trends in complaints and incidents occurring with their devices - MedDev 2.12.1 . Report to National Competent Authority
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