EU MDR GSPR Mapper
Automates the mapping of General Safety and Performance Requirements for EU Medical Device Regulation compliance and technical documentation generation.
The EU MDR GSPR Mapper is a specialized tool designed for biomedical engineers and regulatory affairs professionals to streamline compliance with the European Medical Device Regulation (2017/745). It facilitates the complex task of mapping device features to Annex I requirements, identifies documentation gaps, and assists in drafting critical artifacts like the Summary of Safety and Clinical Performance (SSCP). By integrating directly into the development workflow, it ensures that technical documentation remains traceable, up-to-date, and aligned with Notified Body expectations throughout the device lifecycle, significantly reducing the manual effort required for regulatory submissions.