Retention Requirements of Complaint Medical Devices

J

jawbreaker28

#1
Hello,

How long is one required to retain complaint devices? These devices have already been analyzed and the complaint files have been closed.

How long for regular complaint devices?
How long for MDR (reportable) complaint devices?
 
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R

RunningMommaCT

#3
Hi!

I started my medical device career investigating complaints for a large medical device manufacturer. Implant related complaints were held onto indefinitely. Due to potential product litigation we archived the implants. We only kept instruments which were tied to MDR/MDVs. All other instruements were scrapped/recycled. Our control of records procedure actually stated 55 years for implant related complaints. I think this is quite conservative and that your organization should evaluate the risk associated with its size, complexity to the medical device and potential for litigation. I work for a small start-up company and am setting up my QMS to retain implants indefinitely as well. Good luck to you.
 
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