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Hello All. I'm new to Elsmar and new to dealing with validated products so I hope someone can answer my question below.
Our co manufactures a 510K approved, validated, FDA listed dental guard which is listed as unclassified in the 510K. Currently our acceptance testing criteria for Visual defects on this product is broken up into multiple AQL levels. IE some defects are listed ANSI Z1.4 S/N .4, others at S/N .65, and the rest at S/N 2.5. Our company is making a system wide change to only have one AQL level for all visual defects using whatever the tightest current AQL level is which meets all of our commercial and other medical customers specs. so far. My question is whether or not changing the AQL level for all visual defects to Z1.4 S/N .4 will affect the validation of this particular product and require us to re-validate?
Thanks in advance for your answers.
Our co manufactures a 510K approved, validated, FDA listed dental guard which is listed as unclassified in the 510K. Currently our acceptance testing criteria for Visual defects on this product is broken up into multiple AQL levels. IE some defects are listed ANSI Z1.4 S/N .4, others at S/N .65, and the rest at S/N 2.5. Our company is making a system wide change to only have one AQL level for all visual defects using whatever the tightest current AQL level is which meets all of our commercial and other medical customers specs. so far. My question is whether or not changing the AQL level for all visual defects to Z1.4 S/N .4 will affect the validation of this particular product and require us to re-validate?
Thanks in advance for your answers.