While governments worldwide have a desire to streamline and harmonize the regulatory pathways for medical devices, each regulatory regime is unique i one way o another.
yet, it is possible to minimize the amount of work and maximize the re-use of information when properly planned.
Added to the desire to re-use documentation developed for one region, with the least possible modifications, comes the need to ensure that data collected through clinical trials not only satisfies the regulatory needs, but also proves the Economic HealthClaims you want to make in the different geographies you want to enter.
The puzzle is multi-dimensional and should be reviewed at different stages of the product life cycle.
GB5D helps medical device companies tackle the issue in an organized manner.