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UL and MasterControl publish "ISO 13485- Change? Do I have to?" article

February 11, 2016
With the anticipated release of ISO 13485 this month, UL’s Linda Chatwin Esq., RAC and MasterControl’s Walt Murray, outline the changes and impacts the new requirements will have in their article “ISO 13485- Change? Do I have to?”
With companies wondering if they want to maintain ISO 9001 and ISO 13485 certification, Chatwin and Murray discuss the changes in respect to risk and the “alignment with FDA terms.”  Additionally, the article provides an overview of the impact the changes will have on functions, facilities, processes, records and products.
The entire article can be downloaded by visiting
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