Implementing regulatory monitoring

Implementing regulatory monitoring

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...
Implementing regulatory monitoring

Optimising international approvals

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...
Implementing regulatory monitoring

Validating special processes

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)....