Release / Servicing of Medical Device Sub-Assemblies


Hi all,

We are a medical device manufacturer in the EU, we are ISO 13485-certified. We manufacture an electromedical product composed of several sub-assemblies or structures that are then mechanically assembled and sent to customers. For simplicity, we can call them parts A, B and CV.

We do not sell parts A, B or C separately to customers, but we can manufacture and assemble them independently within our production system.

When we release a new device, we assemble the whole system (A+B+C) and we do a complete system verification to check everything works. Then, we have a release checklist that is completed and signed off by the release responsible (PRRC). This is done for a full device (A+B+C), which includes the whole assembly.

However, if part B breaks at the customer's place, we can simply send this part to them. They can keep their part A and C.
  • How does this fit within the ISO 13485 framework? Is it under the servicing clause?
  • Would you have a separate release for these individual parts? e.g. the release responsible (PRRC) signing off the release of this part. This seems a bit weird to us because the release responsible is not involved in serviced or maintained devices, we only "release" newly manufactured devices, which are later serviced according to instructions.
I hope anyone has a bit of insight on how you do this within your organizations! :)


Involved In Discussions
The replacement process needs to be validated. This should also include a UFMEA (similar to a PFMEA) to understand all the ways a customer could screw it up and to make sure the risks of errors or incorrect results are minimized. You'll probably want to send a copy of the instructions with the part so the customer doesn't have to go look for the instructions or doesn't maintain their own copy which could become outdated.

Regarding sending out service parts, there needs to be release criteria along with inspection/release evidence. Also you'll need to consider packaging for parts and demonstrating shipping robustness of the individual parts since the assembly shipping validation may not be applicable to an individual part.

You'll also need to keep record of what parts (id, batch #, etc.) were sent to which customer to replace parts in which SN of assembly so that you have complete device history records.

I'm not familiar with the PRRC needing to directly approve the release of each part. But this is part of servicing validation. Just like process validation, the PRRC doesn't need to actually sign off on the release of individual assemblies, but they are accountable that the processes to develop the processes were followed and the processes you are going use are appropriate. So you'll need evidence that when followed the process output provides a part (assembly) that meets requirements and they operators (users in this case) will have evidence they completed the servicing correctly. (an example would be when powered on the units does a self-test and illuminates a green-light indicating ready for use, or a yellow light if it is not in a usable state).
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