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August 13, 2020 @ 9:00 am - ISO 14971:2009 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals Utbildning - Riskhantering för medicintekniska produkter -ISO 14971 - Under utbildningen får du grundläggande kunskap om kraven på riskhantering, förstår Medicintekniska produkter - Tillämpning av ett system för riskhantering för medicintekniska produkter (ISO 14971:2019) - SS-EN ISO 14971:2020This document Kursen går igenom hur ISO 14971:2019 påverkar design, utveckling, tillverkning ett certifikat utfärdat av det internationellt beryktade BSI Training Academy. ISO 14971. Course length 2 days.
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Hear from Dr Peter Bowness, Medicinal and Biologics Technical Team Manager, about the updated ISO 14971 and what has changed from the previous version of the standard. BSI Training - ISO 14971:2019 Risk Management for Medical Devices webinar The current state of risk management based on ISO 14971 and other applicable product safety standards including those related to processes and those related to specific medical device products. How risk management is audited during MDSAP audits and how that relates to country specific requirements for risk management activities or risk-based ISO 14971:2007 and EN ISO 14971:2012 As you likely know, the EN version was applicable if you were selling medical devices in Europe.
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ISO 14971.
This document contains the official version of EN ISO 14971:2019. Upon completion of this training, students will be able to: Overview of the key changes in ISO 14971:2019 Risk Management - Medical Devices. Risk Management Overview including Risk Plan, Risk Assessment, Risk Control, Risk Overall Evaluation, Risk Report, Risk Monitoring. Practice the basics of risk management. This course offers practical insight on applying ISO 14971, the knowledge required to apply a risk management process, and how it relates to the product life cycle.
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Dessutom uppnådde TransPerfect även ISO 18587- Training through providing information linked to medical or surgical of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01). Bon #training à tous!
Rek. 26,75 €. +1. Teamgoal 23 training
Enzyme is built for 21 CFR 11 and 820 plus ISO 13485 and 14971.
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This includes ISO 13485 Lead Auditor training, MDSAP (Medical Device Single of single use point of care tests, a reader as well as training to medical staff.