The Risk Management Maturity Model (RMMM) is a collaborative industry initiative dedicated to improving risk management practices in the development and lifecycle management of medical products. By bringing together diverse expertise from across the industry, the initiative seeks to establish a clear framework that helps organizations evaluate and strengthen their risk management capabilities.
RISK MANAGEMENT MATURITY MODEL
The Risk Management Maturity Model (RMMM) is a collaborative industry initiative dedicated to improving risk management practices in the development and lifecycle management of medical products. By bringing together diverse expertise from across the industry, the initiative seeks to establish a clear framework that helps organizations evaluate and strengthen their risk management capabilities.
The Risk Management Maturity Model (RMMM) is a collaborative industry initiative dedicated to improving risk management practices in the development and lifecycle management of medical products. By bringing together diverse expertise from across the industry, the initiative seeks to establish a clear framework that helps organizations evaluate and strengthen their risk management capabilities.
Purpose
Advance first-principles-based technical best practices for Medical Product Safety and Effectiveness, and in doing so deliver:
Clarity: Activities directly aligned with intended use, safety, and patient outcomes.
Efficiency: Resources focused on what matters, not redundant paperwork.
Innovation: Safe, responsible advancement even when regulations lag.
Regulatory Confidence: Structured frameworks that demonstrate why a product is safe and effective, not just whether rules were followed.
Our Guiding Principles
Patient Focused & Decision Driving
Risk management drives patient-focused decisions for safety and effectiveness, not just compliance paperwork.
Proactive & Prevention Focused
Anticipates and mitigates risks early to prevent harm, delays, and costly reworks.
Informed & Lifecycle Integrated
Fed by product information, risk management drives design and development decisions across all stages of the product lifecycle.
Regulatory Aligned
Provides clear, compelling evidence for global regulatory approval and compliance.
Cross-Functional & Systems Oriented
Unifies teams (safety, quality, engineering, regulatory) for holistic and consistent decision-making.
Transparent, Storytelling & Trust Building
Communicates risk insights and maturity through evidence and compelling narratives to build stakeholder trust.
Practical & Value-Driven
Implements efficient and scalable practices that deliver both safety and business value.
Leadership & Culture Driven
Elevates risk management as a leadership priority, embedding it into organizational culture.
Fit-for-Purpose Processes & Tools
Leverages optimized processes and digital tools to ensure consistency, traceability, and actionable evidence.
Learning Oriented
Captures lessons learned and post-market evidence to continuously expand knowledge and drive improvement.
Patient Focused & Decision Driving
Proactive &
Prevention Focused
Informed & Lifecycle Integrated
Regulatory Aligned
Cross-Functional & Systems Oriented
Transparent, Storytelling & Trust Building
Fit-for-Purpose Processes & Tools
Practical & Value Driven
Leadership & Culture Driven
Learning Oriented
Members
Co-Chairs
Coming Soon
Overview
Scale
The Risk Management Maturity Model (RMMM) initiative is supported by a growing cross-industry community of over 70 volunteer contributors from many different companies working together to define and advance best practices in risk management.
Member Companies
Industry Representation
The initiative draws on expertise from multiple sectors of the medical product ecosystem. This diversity of experience ensures the maturity model reflects real-world risk management practices across different industries and product types.
Our collaboration members have expertise in:
-
Pharma and Drug Devices
-
Medical Devices
-
Consulting and Services
Governance
The RMMM initiative operates through a collaborative governance model that combines leadership, technical expertise, and broad industry participation.
-
Co-Chairs – Provide strategic leadership and advocate for the initiative across the industry.
-
Technical Advisors – Ensure alignment with global standards and regulatory expectations.
-
Core Team – Designs the maturity model framework and leads domain development.
-
Domain Sub-Teams – Subject matter experts who develop detailed content within specific areas.
-
General Reviewers – Provide feedback and help validate the model from a broad industry perspective.
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AbbVie
B Braun
BD
Dexcom
GessNet
Gilead
GSK
Lilly
Medtronic
Merck
Olympus
Pfizer
Roche
West Pharma
Updates
Core Team Kickoff (29 Jan 2026)
Co-Chair Kickoff (Sep 2025)
Kickoff Meeting (14 Jul 2025)
How to Participate
Co-Chairs: Senior industry leaders who provide executive-level guidance, strategic direction, and advocacy for the Risk Management Maturity Model(RMMM).
Technical Advisors: Global thought leaders or standards experts who ensure the RMMM is aligned with global risk management-related initiatives.
Core Team Members: Work as part of the core team to design the maturity model framework across domains and lead a sub-team to develop the detail content of a particular domain.
Domain Sub-Team Members: Subject matter experts (SMEs) who contribute content and review drafts for their domain.
General Reviewers: Provide feedback on the overall RMMM framework and deliverables.
<0.5-hours monthly commitment
<1 hour monthly commitment
<3 hours monthly commitment
<2 hours monthly commitment
<1 hour monthly commitment
Associated Events
Legal Considerations
Antitrust Statement
This group includes members who may be competitors or potential competitors in certain products or services. All participants acknowledge and agree to comply fully with applicable antitrust laws. In particular, the group will not engage in any discussions or reach any agreements that could restrict competition, including the sharing of competitively sensitive information such as pricing, costs, margins, confidential R&D or non-public strategic plans. Members are expected to remain vigilant and report any concerns regarding compliance with the antitrust laws.
Contact Information
Support Hotline
Tel: (916) 292-8910
Fax: (916) 943-0940
Email: gessinfo@gessnet.com
Headquarters
3941 Park Dr. 20-180
El Dorado Hills, CA 95762
Purpose
Advance first-principles-based technical best practices for Medical Product Safety and Effectiveness, and in doing so deliver:
Clarity: Activities directly aligned with intended use, safety, and patient outcomes.
Efficiency: Resources focused on what matters, not redundant paperwork.
Innovation: Safe, responsible advancement even when regulations lag.
Regulatory Confidence: Structured frameworks that demonstrate why a product is safe and effective, not just whether rules were followed.
Our Guiding Principles
Patient Focused & Decision Driving
Risk management drives patient-focused decisions for safety and effectiveness, not just compliance paperwork.
Proactive & Prevention Focused
Anticipates and mitigates risks early to prevent harm, delays, and costly reworks.
Informed & Lifecycle Integrated
Fed by product information, risk management drives design and development decisions across all stages of the product lifecycle.
Regulatory Aligned
Provides clear, compelling evidence for global regulatory approval and compliance.
Cross-Functional & Systems Oriented
Unifies teams (safety, quality, engineering, regulatory) for holistic and consistent decision-making.
Transparent, Storytelling & Trust Building
Communicates risk insights and maturity through evidence and compelling narratives to build stakeholder trust.
Practical & Value-Driven
Implements efficient and scalable practices that deliver both safety and business value.
Leadership & Culture Driven
Elevates risk management as a leadership priority, embedding it into organizational culture.
Fit-for-Purpose Processes & Tools
Leverages optimized processes and digital tools to ensure consistency, traceability, and actionable evidence.
Learning Oriented
Captures lessons learned and post-market evidence to continuously expand knowledge and drive improvement.
Patient Focused & Decision Driving
Proactive &
Prevention Focused
Informed & Lifecycle Integrated
Regulatory Aligned
Cross-Functional & Systems Oriented
Transparent, Storytelling & Trust Building
Fit-for-Purpose Processes & Tools
Practical & Value Driven
Leadership & Culture Driven
Learning Oriented
Members
Outline of Structures
Scale
The Risk Management Maturity Model (RMMM) initiative is supported by a growing cross-industry community of over 70 volunteer contributors from 14 separate companies working together to define and advance best practices in risk management.
Domains
The initiative draws on expertise from multiple sectors of the medical product ecosystem. This diversity of experience ensures the maturity model reflects real-world risk management practices across different industries and product types.
Our collaboration members have expertise in:
-
Pharma and Drug Devices
-
Medical Devices
-
Consulting and Services
Governance
The RMMM initiative operates through a collaborative governance model that combines leadership, technical expertise, and broad industry participation.
-
Co-Chairs – Provide strategic leadership and advocate for the initiative across the industry.
-
Technical Advisors – Ensure alignment with global standards and regulatory expectations.
-
Core Team – Designs the maturity model framework and leads domain development.
-
Domain Sub-Teams – Subject matter experts who develop detailed content within specific areas.
-
General Reviewers – Provide feedback and help validate the model from a broad industry perspective.
Updates
Core Team Kickoff (29 Jan 2026)
Co-Chair Kickoff (Sep 2025)
Kickoff Meeting (14 Jul 2025)
How to Participate
Associated Events
Contact Information
Support Hotline
Tel: (916) 292-8910
Fax: (916) 943-0940
Email: gessinfo@gessnet.com
Headquarters
3941 Park Dr. 20-180
El Dorado Hills, CA 95762