How long the QMS must be maintained after device EOL?

S

SGquality

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#1
#1
How long the QMS must be maintained after a medical device is discontinued - would that be the last lot plus the expected lifetime of the device?

Thank you
 
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A

Alan_DB

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#2
#2
SGquality said:
How long the QMS must be maintained after a medical device is discontinued - would that be the last lot plus the expected lifetime of the device?

Thank you
Click to expand...
That is the ISO 13485 requirement, but you also need to consider where you distribute your product to and the applicable regulatory requirements - E.g. EU under MDR is 10 years after last placed on market for devices, 15 years for implantable devices. Japan is also 15 years I believe.
 
A

Alan_DB

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#4
#4
PART 820 -- QUALITY SYSTEM REGULATION
Subpart M - Records
Sec. 820.180 General requirements.
(b) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
 
Ed Panek

Ed Panek

QA RA Small Med Dev Company
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#5
#5
In addition to your QMS requirements, your customer/supplier agreements may have input to this.
 
S

SGquality

Quite Involved in Discussions
#7
#7
In the event of taking the device off the market and shutting down an Established Registration, is it just enough to deregister and delist on FURLS or we need to communicate to FDA separately?
 
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