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ISO 13485/MDR certification

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Lucia Created:   Nov 06, 2022 Last commented:   Nov 08, 2022

ISO 13485/MDR certification

 We are preparing for the certification according to ISO 13485 and MDR.  Our company has 14 meddev families. Is it possible to limit the scope of the certification on 2 families only or we HAVE to have all 14 families covered (risk file, tech file, etc)? So technically we would use the CE mark on two products initally and move forward.

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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 Nov 08, 2022

Yes, it is possible to limit the scope to only 2 families of medical devices. But you have to be aware that devices that you did not certify you are not supposed to sell as medical devices. 

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Nov 06, 2022

Nov 08, 2022