M
medic61
After following this site for a while I hope there is someone here that can answer my question. I hope I have explained it okay and that it is in the right section of the forum.
My company has a mature quality system in place (medical devices) and all the requirements that go along with it. Recently other companies have asked us to make devices (Class I/FDA or Class IIa for EU) for them. We in turn would purchase the devices from them for our customers. After reviewing the requirements for a Contract Manufacturer I cannot find out who is responsible to create and maintain the technical/device master file, us or them. We are not doing any labeling nor design. These products have been made before by other companies and are not new to the market. Neither of the "owners" do any manufacturing. If these were our products they would fall within the scope of products we already make and would not have a seperate technical or DMF of their own, just included in the file with the other products. One of them has mentioned being able to access the files if they need to which is not permitted under our QS.
I would like some further information before I discussing this topic with them. How do others handle the paperwork in this case?
I appreciate your help.
My company has a mature quality system in place (medical devices) and all the requirements that go along with it. Recently other companies have asked us to make devices (Class I/FDA or Class IIa for EU) for them. We in turn would purchase the devices from them for our customers. After reviewing the requirements for a Contract Manufacturer I cannot find out who is responsible to create and maintain the technical/device master file, us or them. We are not doing any labeling nor design. These products have been made before by other companies and are not new to the market. Neither of the "owners" do any manufacturing. If these were our products they would fall within the scope of products we already make and would not have a seperate technical or DMF of their own, just included in the file with the other products. One of them has mentioned being able to access the files if they need to which is not permitted under our QS.
I would like some further information before I discussing this topic with them. How do others handle the paperwork in this case?
I appreciate your help.