Stop starting from blank spreadsheets. MedMI equips regulatory consultants and QA/RA agencies with structured workflows to build and manage ISO 14971 compliance packages in a fraction of the time.
Built specifically to address QA/RA agency bottlenecks.
Save pre-configured risk profiles, common controls, and mitigation guidelines as custom templates. Reapply them across new client device projects with one click.
Organize documents under client-specific folders and workspaces. Grant direct view/edit access to individual clients under a controlled environment.
Deliver fully formatted Word, Excel, and PDF reports branded with your agency logo or the client's corporate identity. Ready for direct technical file inclusion.
Map software safety lifecycles (IEC 62304) and usability engineering (IEC 62366) directly to the hazards, establishing complete traceability without separate files.
Instantly compile baseline electromechanical, software, and usability hazards. Reduce initial brainstorming times from weeks to hours, focusing on review and approval.
Generate and export clean narrative RMF plans, interactive 5x5 matrices, risk analysis sheets, and post-market tracking forms in Word, Excel, and PDF formats.
Our Consultant Plan includes 15 active client projects, client workspaces, and white-label exports for ₹12,999 per month. Accelerate your firm’s compliance turnaround and win more projects.
