Question
As originally asked by
Does a medical device manufacturer have to re-label research only products (animal research only, not for use in humans) as investigational use (per 21 CFR 812) for use in IRB or IDE?The devices are not cleared and some may or may not be on a path to...
Tomorrow there is a medical device webinar from PRISYM ID on how to successfully integrate SAP with your label lifecycle management solution. This solution will accelerate your business processes through end-to-end automation. Integration benefits in...
For 10 years, Dexcom made this claim: Continuous glucose monitoring (CGM) is intended to supplement, not replace, a blood glucose meter. A confirmatory finger stick is required prior to treatment. This is known as an adjunctive claim, because the mon...
As originally asked by Erin Seiler, MBA Account Manager, Color & Additives North America at PolyOne A huge trend in labeling we are seeing on the manufacturing end, is a change from stickers or other forms of identification to laser marking technolog...
I am using Avery labels on a A4 sheet and a desktop laser printer. Can anyone suggest me software to create labels with a bar code type GS1-128 Datamatrix? I found the software "Nice label pro" that would suit me, is there any other on the market? Th...
source: https://www.linkedin.com/groups/78665/78665-6211618860588761089
I would like to know if some of you have issues with this procedure ? What is your Notified Body and does it still accept OBL procedure for CE marking ? I think that is a huge concern for many Medical Device companies and it deserves a discussion. so...
Shanshan (Samantha) Chen (ASQ CQA)
RA/QA professional in Medical devices industry, seeking to new opportunity.
August 2016
Do anybody know that is there any labelling requirement for medical device’s Wi-Fi function in Canada? I check the label regulation and they did not mention Wi-Fi, thanks!source: https://www.linkedin.com/groups/2070960/2070960-6176002121310175232
Is it mandatory to have GS1 GTIN barcoding on medical device? I understand US FDA has made UDI mandatory, but for a company which is not targeting US market is it good to have a GS1 GTIN barcoding in place. source: https://www.linkedin.com/groups/786...
