I have just taken over the management of a business. How can I get an objective view of its internal operations? An inventory of the business is critical to understand not only its functioning, but also its culture. An objective vision often requires external advice,...
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...
