Medical Device Repair Centers

rmurp

Starting to get Involved
#1
We will be sending our medical devices to various repair centers throughout the world to have small repairs done, replace cords, lens and the like. Can someone share how they control these repair centers and give an example of the quality agreements between the two companies?:thanx:
 
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Mark Meer

Trusted Information Resource
#2
You'd treat the repair centers like suppliers (of a "repair" service).
As such, the requirements are for you to define, presumably based on some sort of risk-assessment and any applicable regulatory requirements (e.g. FDA 21 CFR 820.200)

In an agreement you can dictate such things as:
- The scope of repairs they can perform
- The established procedures that must be followed when conducting repairs
- What equipment & parts they can use, and where they get them from
- Required training/qualification of repair technicians
- Required post-repair testing
- Records they are required to maintain (you may stipulate that these are sent to you, or how they are maintained/reviewed)
 

yodon

Staff member
Super Moderator
#3
Good list by @Mark Meer. I'd probably add "Information they are required to communicate to you" (especially if you don't get the records). Both 820 and 13485 have requirements that service information be assessed to determine if regulatory reporting required and if there's indication that improvements / changes are warranted.
 
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