I have to perform a clinical evaluation of my medical device (MD). How do I do this? The approach is to follow specific guidelines and mainly MEDDEV rev4 2.7.1 and regulation (EU) 2017:745 Annex 14 ! But this is not quite as simple… Should I do a clinical trial?...
Does the classification of my device have an impact on placing it on the marketing? Classification of a device is an essential step to determine an optimal regulatory strategy to market the right product, a compliant product, safe and effective in the target markets....
I subcontract a large part of my activities to specialised subcontractors. How can I control them and make sure they are working properly? As a manufacturer, you are solely responsible for the authorities, regardless of the number of subcontractors you need to produce...
I am manufacturer of medical devices. Must I validate the software that I use in my production, preparation service and control activities? Regulatory requirement ISO 13485: 2016 specifies that the organisation must establish documented procedures for the validation...
I have to demonstrate the compliance of my electro-medical device with EN 60601-1 ed.3.1 in a very short time and in order to sell it worldwide. How can I do so? With Nex’elec, our team takes care of it for you: Select the testing laboratory that will be able to...
