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Applicable standards to comply

ISO 13485 & EU MDR
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jjpei Created:   Dec 03, 2018 Last commented:   Dec 10, 2018

Applicable standards to comply

ISO 13485 & EU MDR
If my company is working on providing services (etc lab imaging services), which standard should we be certified on ? Do we still need ISO 13485?
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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 Dec 10, 2018

Service is considered a type of product. Therefore, ISO 13485 would be appropriate for you.

For further information feel free to look at the following article:
- Checklist of ISO 13485 implementation and certification steps: https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

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Dec 03, 2018

Dec 10, 2018

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Some Information regarding ISO 13485 and ISO 9001

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