Moshe Yuval ShapiroSep 18, 20222 minEN/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...
Moshe Yuval ShapiroSep 15, 20222 minEN/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...
Moshe Yuval ShapiroJun 6, 20222 minEN/ISO13485 – Quality Management Systems: What went Wrong? (Part I)The EN/ISO1385: 2016 –Medical Devices—Quality Management Systems