1.      Identify Total Design Control Requirement
Review of specific design control requirements, determine their source and identify implementation methods.

·         Design Control

·         US – Food Drug and Cosmetics Act & 21 CFR Part 820

·         EU – Medical Device Directive (MDD) & EN ISO 13485:2012

·         Canada – Canadian Medical Device Regulations (CMDR) & ISO 13485:2003

·         Conformity Assessment Paths

·         US – Premarket Submissions

·         EU – MDD Annex II Technical Files & Design Dossiers

·         Canada – Medical Device License

·         Identify Total Design Control Requirements

2.      Developing a Project Plan
Analysis of a small example project, identify stages and develop a Work Breakdown Structure (WBS) and a Gantt chart for the project.

·         Planning Stages

·         Interfaces

·         Project Management Techniques

·         Action List

·         Work Breakdown Structure (WBS)

·         Gantt Chart

·         Critical Path Method (CPM)

·         Program Evaluation and Review Technique (PERT)

·         Developing…