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)