The Rimsys platform supported our notified body audit by centralizing product registration data, enabling same-day responses to auditor inquiries. Through centralized tracking of market authorizations in Rimsys, the audit concluded with no nonconformances related to device marketing authorization. The platform continues to serve as our global regulatory hub, helping teams efficiently access and document market release authorizations.”

This platform brings together all of our regulatory information in one place, including license approvals, registration lifecycles, product releases, and change management assessments. My RA colleagues and I use the system every day and have engrained in our transformed culture and SOPs. The system is even more powerful when everyone is using it consistently. If use is not consistent through the regulatory organization, the benefit will be difficult to achieve. Rimsys customer support is also very open to hearing our ideas, challenges, suggestions, and always offer up possible solutions along with implementation support.

Rimsys is intuitive and well-structured, making it easy to manage global market authorizations without getting lost in administrative complexity. I especially appreciate how logically the platform organizes regulatory documentation, submission timelines, and country-specific requirements. It reduces manual tracking and gives me confidence that nothing is slipping through the cracks.