Hi, I have a problem with LVD and standard 62368-1, I'm not sure if our device should comply with them. We are designing a medical device with...
Dear Team, A short one linked to Medical Device labeling, if you allow me: My products are medical device class III in Europe and class II in...
I'm working to transfer all of our paper documents into electronic copies managed in our EQS. We're currently working with ISO13485 and 21CFR 820...
The release follows a review of adverse events reported between 2009-2016....
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