How can I optimise submissions for a MD that I want to market in different countries? Challenges of a structured regulatory strategy The goal, after having clearly defined the classification of your device by country, is to determine strategically the common...
How important is the validation of special processes? Why do we validate special processes? A special process is a process that provides a product whose compliance with the requirements cannot be 100% controlled routinely (e.g. cleaning, sealing, sterilisation)....
My production subcontractor informs me of a change in its manufacturing process and sends me its validation change file. Should I inform my notified body? There are a number of guidelines that guide you in determining the importance of a change in design, production...
I want to register my products in the US, Canada and / or Australia. How do I do it? The solution: nex’reg Nex’reg allows you to entrust the entire process of registering your products to obtain approval and benefit from our knowledge of the regulation in...
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,...
