IVD Design and Development

IVD Design and Development is a one day course designed for those involved in the development of In Vitro Diagnostic Systems (IVD) who wish to have not only an enhanced understanding of the requirements of ISO 13485:2003 – Medical devices – Quality Management System Requirements and a method of implementation of each of the provisions of this standard, related to product realisation; but who are also determined to efficiently develop IVD technology for commercial success. The course is specifically aimed to communicate how an effective product development process facilitates a smooth regulatory pathway, avoiding the many pitfalls along the way, and resulting in a reduction in project duration.

Course Overview

 IVD Training provides an intensive and in-depth one day course covering the elements of section 7.3 of ISO 13485 (Product Realisation) with an emphasis on imparting detailed knowledge of the practical implementation and use of the standard.

Upon completing this course, participants will be able to develop IVD systems with knowledge of the regulatory requirements of the development process.

Who Should Attend

The course is aimed at:

  • Scientists and engineers involved in the development of IVD systems. 
  • Project, Line and Operations Managers controlling or influencing the development of IVD systems.

Course Outline

One-day (9:00am to 4.30pm)

Introduction

Design and Development Planning

  • ISO 13485 Requirements
  • Application of the PMBOK Model of Project
    Management to Medical Devices
  • Sample Project Management Plan

Design Inputs

  • ISO 13485 Requirements
  • Essential Principles 
  • Requirements Basics

Morning Tea

Design Outputs

  • The Design History File (DHF)
  • The Device Master File (DMR)
  • Meeting input requirements
  • Information for purchasing, production and servicing
  • Characteristics defining safe and effective operation

Design and Development Review

  • When does this occur and why?
  • The ‘Golden Eggs’ of know-how
  • Issues Management System
  • Summary

Lunch

Design Verification

  • What is Design Verification?
  • The frightening part!!
  • Design History file
  • Practical Examples Design Validation
  • What is Design Validation?
  • Types of Design Validation
  • Caution about definitions
  • The specification layer 
  • Design Validation by Clinical Study

Afternoon Tea

Change Control 

  • What is Change Control?
  • How does it work in practice?
  • The three ”F’s”
  • Document tree
  • Practical Examples

Presented by: Steve Marshall and Dr John McCarthy

Investment:

  • Investment $980.00 (incl.GST) per person

For registration and further information please contact Leanne Maslen on 0 2 9318 1005 or leanne.maslen@perficiopd.com.au
Terms & Conditions

  • Any cancellations received 5 working days or less prior to the course commencement date, is subject to full course fee.
  • Participants will receive a formal confirmation and tax invoice at least one week prior to the course commencement date.