S
sueliu - 2012
I have a question regarding the medical device labelling.
ISO 13485 did not mention the requirement for labeling in detail. However, FDA has a few regulations regarding labeling, such as 21CFR 801, General Device Labeling and 21 CFR 820 QMS. Since we are a software company, I am wondering how we should implement this part. To my understanding, we need to have the following components included in the label:
• Name of the software
• Name and address of manufacturer
• The identifier of the device, eg. A number to distinguish the device from others
• Indications for use
• CE mark (since we sell it to Europe)
• Rx sign
However, the fact that the company distributes its product through web server (does not sell packaged software) makes this question even trickier. I am not sure where and how we should “label” the software before they are distributed. Do you have any suggestions for me to implement this part?
Any help is appreciated! Thanks
Sue
ISO 13485 did not mention the requirement for labeling in detail. However, FDA has a few regulations regarding labeling, such as 21CFR 801, General Device Labeling and 21 CFR 820 QMS. Since we are a software company, I am wondering how we should implement this part. To my understanding, we need to have the following components included in the label:
• Name of the software
• Name and address of manufacturer
• The identifier of the device, eg. A number to distinguish the device from others
• Indications for use
• CE mark (since we sell it to Europe)
• Rx sign
However, the fact that the company distributes its product through web server (does not sell packaged software) makes this question even trickier. I am not sure where and how we should “label” the software before they are distributed. Do you have any suggestions for me to implement this part?
Any help is appreciated! Thanks
Sue