Design and Development
When a medical device needs to be designed and developed it is favorable to follow a certain structured approach. By following a Product Development Cycle (PDC) and Design Control process it is guaranteed that all necessary regulatory steps are taken. The produced documentation output ensures the compilation of a Design History File (DHF). The information collected in the DHF can be used to compile the Technical Dossier to be submitted for European market approval. MDProject has set up a structure to minimize the amount of paper work but fulfill all the regulatory requirements needed for submissions by using the harmonized submission STED format (Summary Technical Document).