Changes and conformity to regulatory requirements at the same time are part of the daily routine when developing and manufacturing medical devices. Quite often a balancing act impends, with an inflexible water fall model on one side and the wish for agile development on the other side. This requires processes that are robust and reliable when it comes to regulatory requirements, but also support agile development to profit from its advantages. The challenges lying within the development of complex systems can be coped with by using modern methods for Product Lifecycle Management, Requirements and Test Management, Technical Change Management and Project Management.
Advantage through Efficiency.
Companies underlying market-specific regulatory requirements for development processes and considering its economical interests at the same time, can give themselves a competitive edge despite the increasing obligations. Knowledge in this Regulatory Affairs area gains an advantage as well.