Ex 125 - Design Control for the Medical Device Industry

Overview

This TWO-DAY course provides the information needed to meet the required regulations driven by ISO 9001, QSR, and the European Medical Device Directives. Learn how to deal with the cultural and business issues that impact Design Control activities.

Attendees will gain a thorough understanding of:

• The need for Design Control
• Similarities and differences between ISO 9001, ISO 13485, and QSR
• Documentation and required records
• How to establish a simple model for new product design development
• Technical file and risk analysis
• What inspectional strategies are used by the FDA

Benefits

• Understand how to meet QSR requirements for Design Control
• Keep documentation to a minimum, while still meeting requirements
• Bring new or enhanced products to market faster
• Demonstrate to regulatory agencies that products are developed under a controlled process, assuring safety and effectiveness

Minimize product liability related risks

Key Session Topics

• What the FDA expects now
• A detailed look at requirements
• Issues that impact Design Control
• EU Directive (CE Mark) requirements
• Risk Analysis
• How to create a CE Marking technical file
• How to compile a design dossier
  

Who Should Attend

• R&D managers / engineers
  
• RA / QA Managers / engineers
  
• Management representatives
  
• Members of multi-discipline design teams
  
• Sales and marketing management
• Product, project, program managers
• Internal auditors