ISO13485, FDA, MDD 2007, CE Labelling

R

rick76

#1
Is their someone kind enough to share labeling, packaging and preservation control procedure? I working for a start-up medical device company that requires a procedure how to control labels, packaging and perservation of contol... please advise!
 
Elsmar Forum Sponsor
A

arios

#2
Wish I had one procedure to share but I don't. My apologies

The least I can recommend is you to take the section 820.120 of the QSR as a baseline to start with. This is the link:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.120

A good procedure for label control would address the req's of 820.120, whereas ISO 13485 does not really specify much. Much of the additional controls are learned by experience, e.g. how to make sure you consistently print the correct shelf life on product, how to control prnted materials other than labels, segregation practices, etc.

I hope this helps
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Is their someone kind enough to share labeling, packaging and preservation control procedure? I working for a start-up medical device company that requires a procedure how to control labels, packaging and perservation of contol... please advise!
Hi,

Maybe you will find some useful samples in the FDA's QSR manual, chapters 11 (labeling), 13 (packaging) and perhaps 14 (storage). Exhibits are at the end of each chapter.

Cheers,
Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Hi Ronen

Do you have the link available?
Sure, here it is:

http :// www. fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/default.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

Cheers,
Ronen.
 
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