A regulatory strategy is a critical component of the medical device design process, guiding the entire development from concept to market launch. It outlines all activities necessary to define the project timeline and navigate the device development process through to implementation. The strategy ensures compliance with regulatory and normative requirements, streamlining the path to market and minimizing risks, errors, and delays.
A well-crafted regulatory strategy serves as a detailed roadmap, covering everything from device qualification and classification to clinical development and technical documentation. It not only helps in maintaining regulatory compliance but also assists in identifying potential risks early in the development cycle.