case report guidelines - orcanos...of products in the medical device environment spineassist - since...

orcanos

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!