• You may have some operative regulatory activities typically outsourced and need continuously support.
• You have an „old“ medical device in your portfolio, and you realized that the current Technical Documentation needs an update to get it aligned with the state of the art. How to do this in a most effective way.
• You bought a Startup to enlarge your Portfolio. Now the Technical Documentation and the Quality Management Systems needs to get aligned to generate a common regulatory and quality understanding.
• The development of a new device is running in a delay, but you want to keep the timeline for the launch. How to organize regulatory activities by an overlap of running development steps.
