Thank you for the webinar, it was useful.
But I would like to consult a bit more….Could I?
This is regarding certified QMS according to ISO 13485.
MDR does not have indication that QMS must to be certified, there is indicated minimal requirements for QMS. Isn’t it enough?
In *** we have accredited notify body, and they told that there is no information or indications about certified QMS, we are new to this field, and as I understood form your webinar this is new changes, and that there still misunderstandings possible.
If you would be able to advice me I would be really grateful.