Manufacturer in ISO 13485

Vignesh M

Hi everyone. Myself vignesh, QA & RA engineer at cureous labs, Bangalore.I have one doubt. We are doing procurement for our product. Then manufacturing of different components is done by different vendors like vacuum casting and PCB membrane printing. Then we are doing the assembly, testing, QC, labelling, packaging, and distribution. Do we call ourselves as manufacturer of the device? Because we have all the departments together in the office like prototyping & assembly area, soldering station, RND area, designing, Testing everything. But we can segregate all the departments and take control of it. Can we call our place a manufacturing site.


Super Moderator
If your company's name goes on the label, then you are the legal manufacturer. If you are putting the finished device together but someone else's name goes on the label, then you are the contract manufacturer. Either way, "manufacturer" seems to be in scope for you. Curious why you would have a doubt here?
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