Verification

[laslo3001]

Hi everyone,

Looking for some advice on verification.

For labelling - the output would be the label or document containing label e.g DMR. What would the verification be for this?

For a colour on a medical device - the output ould be the manufacturing drawing or DMR - what would the verification be?

For stability - the verification would be the testing- but what would the output be here? Would you show the info in the IFU?

Thanks in advance for any help

 

[yodon]

For labelling - the output would be the label or document containing label e.g DMR. What would the verification be for this?

First off, "labeling" is a rather broad topic, covering the IFU, on-device labels, packaging / shipping labels, and even website content at times. I'm going to assume for this you are considering the on-device labels. Our test inputs here would be the label spec / drawing. The protocol (verification) would be an inspection. The results would demonstrate that the requirements were met.

For a colour on a medical device - the output ould be the manufacturing drawing or DMR - what would the verification be?

Color is challenging since it can be influenced by many things. Here, though, we'd probably just cite the label spec with color specifications to demonstrate the requirements were met.

For stability - the verification would be the testing- but what would the output be here? Would you show the info in the IFU?

Do you maybe mean "durability" here; i.e., the label can withstand exposure to fluids and such? This is often a "rub" test and the output would be documented evidence that the label met durability requirements (before / after pictures, maybe). Not sure what you mean by "show the info in the IFU."

 

[laslo3001]

First off, "labeling" is a rather broad topic, covering the IFU, on-device labels, packaging / shipping labels, and even website content at times. I'm going to assume for this you are considering the on-device labels. Our test inputs here would be the label spec / drawing. The protocol (verification) would be an inspection. The results would demonstrate that the requirements were met.


Color is challenging since it can be influenced by many things. Here, though, we'd probably just cite the label spec with color specifications to demonstrate the requirements were met.


Do you maybe mean "durability" here; i.e., the label can withstand exposure to fluids and such? This is often a "rub" test and the output would be documented evidence that the label met durability requirements (before / after pictures, maybe). Not sure what you mean by "show the info in the IFU."

Hello,

thank you for your help. Sorry I meant as in shelf life for stability.