I want to develop a medical device. What steps should I take to optimise the design of my new product? ISO 13485:2016 specifies that the agency shall establish documented procedures for the design and development. But what does this really mean? With nex’design,...
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...
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...
