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Implementation, Compliance software, Training

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Guest user Created:   Mar 06, 2023 Last commented:   Mar 06, 2023

Implementation, Compliance software, Training

Hello, we are a research lab and are looking at setting up a diagnostics lab to make 2 of our tests available (plus NHS are interested in using them).
We need to get the lab ISO 15189 accredited but for the tests we perform, do we also need to be ISO13485 accredited?
For one of the tests we supply a urine collection kit. If we are to send the kit to patients for sample collection do we need to be accredited (ISO13485)?
The company we purchase the sample collection vessel from, are already ISO13485 accredited.
We receive the sample from the patient and then perform analysis on it so is the extraction and instrument analysis kits regarded as medical devices?
I'm a little confused so any help would be great

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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 Mar 06, 2023

No, you do not need to have ISO 13485 certification since you are not the producer of the kit. Only the producer needs to be ISO 13485 certified. 

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Mar 06, 2023

Mar 06, 2023