5 Dec 2019 | YOUR NEEDS
I am a medical device manufacturer. Must I set up a regulatory monitoring system within my company? Yes, it is a regulatory requirement, which also has many advantages. Nex’inform allows you to: Have an edge in your market; Save time in anticipating and making...
5 Dec 2019 | YOUR NEEDS
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...
5 Dec 2019 | YOUR NEEDS
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)....
5 Dec 2019 | YOUR NEEDS
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...
5 Dec 2019 | YOUR NEEDS
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...
