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Moshe Yuval Shapiro
Sep 18, 20222 min read
EN/ISO13485 – Quality Management Systems: What went Wrong? (Part III)
In this Part I would like to discuss the actual claim of the Standard's Process Approach. Logistics managers know that the initiation of...
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Moshe Yuval Shapiro
Sep 15, 20222 min read
EN/ISO13485 – Quality Management Systems: What went Wrong? (Part II)
In Part I I discussed the disabiguities that are releated with the EN/ISO1385: 2016 –Medical Devices—Quality Management...
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Moshe Yuval Shapiro
Jun 6, 20222 min read
EN/ISO13485 – Quality Management Systems: What went Wrong? (Part I)
The EN/ISO1385: 2016 –Medical Devices—Quality Management Systems
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