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May I ask which country can accept ISO 13485 and ISO 9001?

ISO 13485 & EU MDR
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Guest user Created:   Mar 18, 2019 Last commented:   Mar 18, 2019

May I ask which country can accept ISO 13485 and ISO 9001?

ISO 13485 & EU MDR
ISO 13485 is accepted worldwide as a benchmark for Quality Management System evaluation for medical equipment. In specific, countries in Asia and the US are also adopting the ISO 13485 standards as part of their regulatory requirements.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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Verlene Law Mar 18, 2019

Answer:

ISO 13485 is accepted worldwide as a benchmark for Quality Management System evaluation for medical equipment. In specific, countries in Asia and the US are also adopting the ISO 13485 standards as part of their regulatory requirements.

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Mar 18, 2019

Mar 18, 2019

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