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TRANSCRIPT
ALM Software Implementation Project
Agenda
• Mazor Robotics
• The Need
• Why ALM System?
• Decision Process
• Process Implemented
• Daily Usage
• What we gained
Mazor Robotics
Mazor Robotics’ Renaissance™ is transforming spine surgery from freehand procedures to highly-accurate robotic procedures, minimally invasive surgery (MIS), scoliosis, and other complex spinal deformity cases.
Renaissance – Clinical Procedure Pre-Operative CT Planning
Robotic Device movement to planned position
Registration (Image Processing)
Upload data to OR Workstation
The Need
• Mazor is a growing company, developing multiple number of products in the medical device environment
SpineAssist - since 2005
C-InSight – since 2009
Renaissance Spine –since 2011
Renaissance Brain – CE and FDA cleared since 2012
• Meet the Standards (ISO13485, IEC62304, ISO14971: 60601 3rd Edt.)
• Growing number of projects, employees and clients
• Stand-alone documents Database Management
Why ALM System?
• Prerequisite conditions
Documentation - High time consuming, low maintenance
Collaboration between departments
Multiple projects
Audits and submissions
Company maturity
Decision Process
• Competitive analysis and market research
Licensing
Implementation project
Routine support
Medical standards compliancy
Usability
Compliance to existing PLM software
Process Implemented
Marketing & R&D:
• Application Lifecycle Management Requirement management (Business, System , Software)
Verification & Validation Management (Tests, Defects)
• Risk Management
Operation:
• CAR (Customer Complaint)
• CAPA
Implementation Process • Business Process Management – Characterize organizational processes – Define process owners – System configuration design
• Implementation – Data migration (Legacy) – Create baseline – System setup
• Training – Group and personal training – Help and support
• Control and Governance – Reports and Alerts
Traceability Coverage
Action Items and Inconsistency Reports
Daily Usage
• Used by the following stakeholders
Project Managers, QA\RA Manager, Marketing-Product Manager SW Developers, SW Testers, Service, Operation Manager, COO
• Pro-Active notifications and alerts
React to regulation inconsistency reports
• Documentation
What we gained?
• Focus
• Transparency and accessibility to knowledgebase
• Product Quality
• Ability to measure organization performance
Thank You!