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The Quality Control Loop - A Compliance Concept
The QC Loop team is creating a new approach on process-oriented control loops to ensure full compliance for medical device manufacturers and supply chains. Step into a lean and easy to use concept. Our goal is to reduce legally applicable requirements to the max by creating smart mangement systems.
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Using an environmental management system generates significantly added value in case legal applicable safety at work requirements are defined as quality objectives...
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The QC Loop team is creating a new approach on process-oriented control loops to ensure full compliance for medical device...
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Following the first reading vote of the Parliament in April 2014 and a Council's informal position in October 2015, the Council and the Parliament agreed on a final text on 15 June 2016. At this moment in time, work is ongoing to translate the final texts in all the EU official languages and to correct technical inconsistencies. Final formal adoption is expected both on the Council and the Parliament sides during the first semester 2017. - http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_de
European Commission
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ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. - http://www.iso.org/iso/catalogue_detail?csnumber=59752
ISO org
