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.
MPSEI is a global, neutral platform for first-principles safety and effectiveness: advancing justified confidence and improving patient outcomes across the medical product ecosystem.
Our starting point is the patient and the intended benefit: what a medical product must achieve, what could prevent that benefit or cause harm, and what evidence supports justified confidence in its safe and effective use.
The pathway begins with First Principles, moves through Safety & Effectiveness, Justified Confidence, and Sound Decisions, and ends with Better Patient Outcomes.
The five-part MPSEI framework chain.
To advance the science and practice of first-principles safety and effectiveness by aligning ecosystem stakeholders around shared first principles and fundamental objectives, and fostering education, collaboration, research, capability and maturity improvement, continuous learning, and recognition of demonstrated organizational proficiency across the global medical product ecosystem.
Safe and effective medical products do not result from compliance alone. They result from sound decisions and organizational proficiency grounded in fundamental truths, cause-and-effect relationships, evidence, engineering, risk management, continuous learning, and improvement.
Start with the patient and the intended benefit. Determine what must be true for a medical product to achieve that benefit safely and effectively, establish the evidence needed for justified confidence, and integrate that framework into product development and lifecycle management.
Systematically apply inversion thinking within forward-thinking decision making. As we determine what is wanted or intended and how to achieve it, deliberately examine what is unwanted but could happen, how and why it could happen, and how it can be prevented or controlled. This first-principles approach integrates risk management into decision making throughout the medical product lifecycle.
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, and provide the foundation for maturity assessment, benchmarking, continuous improvement, and recognition of demonstrated organizational proficiency.
Align diverse healthcare ecosystem stakeholders around shared first principles and the fundamental objectives of medical product safety, effectiveness, and patient outcomes, while fostering collaboration, shared learning, and collective action across organizational, disciplinary, geographic, and lifecycle boundaries.
Support lifecycle confidence through evidence, real-world experience, post-market learning, continuous monitoring, adaptation, and improvement.
Workstreams translate the confidence framework into education, research, and collaboration.
The Risk Management Maturity Model is a collaborative industry initiative that helps organizations evaluate and strengthen risk management capabilities in medical product development and lifecycle management.
Go to RM3RM3 Founding Community
RM3 brings together more than 70 volunteer contributors with professional experience across pharmaceutical, biotechnology, medical-device, combination-product, consulting, and related fields. Participants contribute in their individual professional capacities.
Participants serve in their individual professional capacities unless expressly stated otherwise. Employer affiliations are provided for identification only and do not imply organizational membership, representation, sponsorship, or endorsement.
70+
volunteer contributors
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.
Together, we will improve patient outcomes.
By aligning stakeholders around first principles and building justified confidence in medical product safety and effectiveness.
CollaborateA wireframe clipboard shows outcome record lines and a physiological signal; a single improvement trajectory rises from the record to one validated outcome node.