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Introduction

  • Introduction
  • What is a CSC?
  • Previous CSCs
  • CSO and CSE Skillset

Benefits

  • Benefits of a CSC

Approach

  • PRINCE2
  • Process Flowchart
  • Quality Management System (QMS)
  • Roles & Responsibilities
  • MDR & SaMD
  • Risk Controls
  • Approach to creating a Clinical Safety Case
  • ISO Standards

CSC Stages

  • Pre Project Tasks
  • Stage 1 Project Start Up
  • Stage 2 Project Initiation
  • Stage 3 Managing Product Delivery
  • Stage 4 Managing Product Delivery
  • Stage 5 Managing Product Delivery
  • Stage 6 Managing Product Delivery

Governance

  • Overall Project Governance

Case Studies

  • Feedback and Testimonies
  • Case Studies

Documentation

  • Templates
  • Standard Operating Procedures (SOPs)
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Case Studies

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