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21CFR-820 vs ISO13485 Quality management systems

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Guest user Created:   May 03, 2023 Last commented:   May 08, 2023

21CFR-820 vs ISO13485 Quality management systems

Hello, we purchased the ISO13485 kit from you guys and I have a question.. We have a QMS for our NIOSH/21CFR-820 doing some research the QMS requirements are very similar, the ISO13485 is more company operations and the NIOSH/21CFR-820 is both operations and product. Since we already have the NIOSH/21CFR-820 can we use this QMS for ISO13485?

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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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Kristina Zvonar Brkić May 08, 2023

This depends on what is required by the national or market regulation. If your requirement is to use ISO 13485, then you can use your own QMS but with added elements that are specific to ISO 13485. So, adapt your QMS with particular requirements from ISO 13485.

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May 03, 2023

May 08, 2023