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ISO 13485 vs EN ISO 13485
I need a detailed comparison of ISO 13485 to EN ISO 13485 to illustrate the technical requirements are the same.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Oct 22, 2020
Prefix ISO means that it is an international standard published by the ISO organization. When an ISO is adopted by the European Union, for example, it becomes an EN-ISO.
There is no difference in the requirements between those two standards.
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Oct 21, 2020
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Oct 22, 2020