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Page 2: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

ALM Software Implementation Project

Page 3: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

Agenda

• Mazor Robotics

• The Need

• Why ALM System?

• Decision Process

• Process Implemented

• Daily Usage

• What we gained

Page 4: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

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.

Page 5: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

Renaissance – Clinical Procedure Pre-Operative CT Planning

Robotic Device movement to planned position

Registration (Image Processing)

Upload data to OR Workstation

Page 6: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

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

Page 7: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

Why ALM System?

• Prerequisite conditions

Documentation - High time consuming, low maintenance

Collaboration between departments

Multiple projects

Audits and submissions

Company maturity

Page 8: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

Decision Process

• Competitive analysis and market research

Licensing

Implementation project

Routine support

Medical standards compliancy

Usability

Compliance to existing PLM software

Page 9: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

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

Page 10: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

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

Page 11: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

Traceability Coverage

Page 12: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

Action Items and Inconsistency Reports

Page 13: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

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

Page 14: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

What we gained?

• Focus

• Transparency and accessibility to knowledgebase

• Product Quality

• Ability to measure organization performance

Page 15: Case Report Guidelines - orcanos...of products in the medical device environment SpineAssist - since 2005 C-InSight – since 2009 Renaissance Spine –since 2011 Renaissance Brain

Thank You!