Medical Device QMS Software

Improve efficiency for quicker go-to-market.

Dramatically reduce the time it takes to bring your product to market by speeding up the process for document development, management, approval, notification, and distribution. Use LuminLogic for an acceleration of your medical product lifecycle development and commercialization.

LuminLogic is the platform for:
Best-in-class product lifecycle development
Product Concept Development Management
  • Capturing and managing critical product ideas
  • Approving and managing patent filing
  • Managing feasibility activities
Design and Development Plan Creation
  • Creating methods and tools for team collaboration
  • Developing project tasks and assignments
  • Distributing plans and merging feedback
  • Storing and indexing documents, ensuring access
Design Input/Output Creation and Management
  • Translating concepts into functional, performance, and interface requirements
  • Translating design input to design output (drawings, instructions, etc.)
  • Ensuring design input/output is traceable
  • Distributing input/output for review and merging feedback
  • Storing, indexing, and distributing design input/output
Design Verification and Validation Creation and Management
  • Distributing verification and validation procedures
  • Creating verification and validation plans, strategies, and methods
  • Manage reviews and approvals on verification and validation protocols
  • Maintaining input/output and verification traceability matrices
  • Collaborating on feedback and integrating reviews
  • Maintaining Design History File (DHF) Indices
Design-to-Manufacturing Transfer
  • Facilitating Design Transfer to Manufacturing and obtaining acknowledgments of receipt
  • Ensuring notification of modified design to Manufacturing
  • Maintaining compliance with Device Master Record
Design Change and Configuration Management
  • Distributing change requests for review and approval
  • Assessing impact of changes
  • Assign change request actions to implementation teams
  • Monitoring change implementation
  • Maintaining clear configuration of products and documents
  • Archiving older designs for reference
Risk Management
  • Defining risk management teams and preparing risk management plans (RMP)
  • Create and manage Failure Mode and Effect Analysis (FMEAs) and compliant risk assessment
  • Review and maintain Risk Management Reports
Design Reviews Management
  • Communicating phase and design reviews
  • Defining scope of design review and identifying deliverables
  • Distributing meeting minutes per template and sharing for approval
  • Monitoring completion of action items
Design History File Management
  • Organizing design history file in a logical manner
  • Creating and Maintaining DHF Indices
  • Ensuring accessibility
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