My company sells blue light blocking glasses in the EU. I now want to sell them in the US. I understand they are a Class 1 medical device hence need FDA registration.
As part of FDA compliance I understand I must have and follow a QMS. I understand my QMS is regulated by 21 CFR part 820 and if I understand correctly an ISO 13485:2016 QMS would be compliant with this. Is that correct?
I am therefore interested in your ISO 13485:2016 template which I can use to create my 21 CFR part 820 compliant QMS.