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Verification Activities - Clinical Medical device manufacturer

M

Mark Smith

#1
My company is in the process of moving to a new location and expecting to resume manufacturing in 2 months time. We are a medical device manufacturer that is currently developing devices and manufacturing for clinical evaluation only!!. We have several designs that we have performed verification testing on however, clinical evaluations intended for DESIGN VALIDATION are ongoing and are scheduled for at least 1 more year.
Since validation FOLLOWS successful verification, the manufacturing process as well as equipment used to manufacture the devices will not be validated until we are certain of the final design (AFTER we move to our new location and prior to distributing any approved product)
When we did verification testing at our current location, we required a number of pass / fail tests on 60 devices and allowed zero failures as evidence of 95% confidence/ 95%Reliability for the design.

I am aware that processes and equipment must be re-validated as the result of a relocation but do I need to repeat the design verification testing of these devices?
If so,
Will I need to repeat the sample size of 60 devices?
If not,
Can I significantly reduce the number of units to something around 10 devices?
 
Elsmar Forum Sponsor
D

Don Winton

#2
<font COLOR="#DF0218"><BLOCKQUOTE>I am aware that processes and equipment must be re-validated as the result of a relocation but do I need to repeat the design verification testing of these devices?</BLOCKQUOTE></font>

I would think that the design verification would not have to be if you can show that the process re-validation was satisfactory. Meanwhile, check out the links below for additional info:

http://www.fda.gov/cdrh/comp/designgd.html
http://www.fda.gov/cdrh/comp/designgd.pdf
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/topicindex/topindx.cfm?alpha=d

Regards,

Don
 
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