RM3 Manual V1.0 draft ready for community review
At the June 5, 2026 IMSC panel, the RM3 working group reported that the RM3 Manual V1.0 draft was ready for broad community review and comment.
Improve organizational proficiency and capability to consistently make sound safety and effectiveness decisions by applying first-principles thinking through effective leadership, governance, culture, evidence integration, cross-functional collaboration, and continuous learning. Through the RM3 Framework, this initiative will support organizational assessment, targeted improvement, benchmarking, and recognition of demonstrated maturity.
A workshop dedicated to the First-Principles Decision Excellence & Organizational Maturity initiative. Date and location to be announced.
An RM3 panel introduced the initiative's goals, structure, progress, guiding principles, maturity domains, and initial assessment concepts, with discussion focused on patient safety, sound product decision-making, regulatory alignment, and practical use of the model.
At the June 5, 2026 IMSC panel, the RM3 working group reported that the RM3 Manual V1.0 draft was ready for broad community review and comment.
An RM3 panel at the International MedTech Safety Conference introduced the initiative's goals, structure, progress, guiding principles, maturity domains, and initial assessment concepts.
The first-principles approach to safety and effectiveness engineering was presented at the RAPS Safety Engineering Workshop on February 28, 2026.
Core Team Kickoff occurred on 2026-01-29.
Co-Chair Kickoff occurred on 2025-09-26.
Kickoff Meeting and Survey occurred on 2025-07-14.
A Risk Management Conference Roundtable on 2025-04-23 raised the questions that led to the RM3 initiative.
Use the collaboration pathway to indicate interest in this workstream.
Join initiativeThe Risk Management Maturity Model helps organizations evaluate and strengthen risk management capabilities in medical product development and lifecycle management.
Go to RM3