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.
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
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 08, 2022