Search Results for ISO 13485:2016

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How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Tags: ISO 13485:2016, Quality Management System

How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Categories: Features, ISO, Manufacturing, Medical Devices

Tags: ISO 13485:2016, Quality Management System

ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning By Michael Mezher - Published 23 September 2016

Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ISO 13485:2016 as soon as possible.

Categories: News, FDA, ISO, Medical Devices

Tags: ISO 13485:2016

New ISO 13485: Device Companies Have Three Years to Transition By Michael Mezher - Published 01 March 2016

The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003.

Categories: News, Japan, Canada, Europe, Oceania, US, ISO, Medical Devices, Quality

Tags: ISO 13485, ISO 13485:2003, ISO 13485:2016, Quality Management Systems, QMS