Skip to content
AboutFrameworkInitiativesRM3PeopleEventsResources
Collaborate

Justified confidence in medical product safety and effectiveness.

Independent nonprofit neutral platform. MPSEI is a trademark of Medical Product Safety & Effectiveness Institute.

info@mpsei.org

Institute

  • About
  • Framework
  • People

Work

  • Initiatives
  • RM3
  • Events
  • Resources

Governance

  • RM3 antitrust statement
  • Collaborate
  • Contact

Medical Product Safety & Effectiveness Institute

PrivacyTermsAccessibility

02

First-Principles Risk Management for Medical Products

Systematically apply inversion thinking within forward-thinking decision making. As organizations determine what is wanted or intended and how to achieve it, they deliberately examine what is unwanted but could happen, how and why it could happen, and how it can be prevented or controlled, embedding effective risk management into decisions throughout the medical product lifecycle.

Challenges

Real-world challenges addressed

  • Missed hazards
  • Risks identified too late in development
  • Recurring CAPAs and quality events
  • Inspection findings
  • Warning letters
  • Recalls
  • Supplier failures
  • Cybersecurity events
  • Unexpected post-market signals
Events

First-Principles Risk Management for Medical Products Workshop

A workshop dedicated to the First-Principles Risk Management initiative. Date and location to be announced.

Participate in this initiative

Use the collaboration pathway to indicate interest in this workstream.

Join initiative