Medical Device Design and Development (including risk management)

Medical Device Design and Development (including risk management)  is a two-day course designed for those involved in medical device development and who wish to have an enhanced understanding of the requirements of  ISO 13485: 2003 section 7.3 Design and Development and a method of implementation of each of the provisions of this standard.

Course Overview

The Medical Device Design and Development (including risk management) provides an intensive and in-depth two day course covering the elements of design control with an emphasis on imparting detailed knowledge of the requirements of ISO 13485:2003 - Medical Devices - Quality management systems - requirements for regulatory purposes, Section 7.3 Design and Development.  Upon completing this course, participants will be able to understand design and development planning, design inputs, design outputs, design review and design verification requriements of the standard and shall have a method of implementation of each of these provisions, allowing integration within an overarching project management infrastructure.

Who Should Attend

The course is aimed at:

  • Engineers and scientists involved in the development of medical devices.
  • Project, Line and Operations Managers controlling or influencing the development of medical devices.

Course Outline

Day 1 -  (9:00am to 4:30pm)  

Day 2 -  (9:00am to 4:30pm)   

INTRODUCTION

  • Overview of the Australian regulatory system for medical devices

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

Design Outputs 

  • The Design History File (DHF)
  • Product requirements and system requirements templates
  • The Device Master File (DMF)
  • Overview of FDA model of DHF and DMF requirements
  • 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

Risk Management

  • Risk management planning

Risk Analysis

  • Hazards Analysis
  • FMEA

 

Risk Analysis (continued)

  • Fault Tree Analysis
  • HAZOP

Design Verification

  • What is design verification?
  • The frightening part!
  • Design History file
  • Practical examples 

Design Validation

  • What is design validation?
  • Types of design validation 
  • Cautions about definitions
  • The specification layer
  • Design validation by Clinical Study

 Change Control

  • What is Change Control
  • How does it work?
  • The three "F's"
  • Document Tree
  • Practical examples

Regulatory Submission Requirements

  • What documents are required for a Summary of Technical Documentation (STED)?
  • Declaration of Conformity
  • FDA Submission Requirements

About the Presenter : Steve Marshall PMP AIPM, Chief Executive Officer

Steve has over 30 years of extensive, professional experience in the medical device and telecommunications industries. He has a recognised track record in effective and successful management of numerous product and system development projects, including implantable medical devices, e-commerce terminals, SCADA system development and cryptology based secure data communicated equipment.  Steve is a certified Project Management Professional (PMI USA) and has attained certification from SAI Global in Management Systems Auditing.

The Perficio Product Development team can provide extensive training in every aspect of medical device development at the executive, managerial and operational levels. Exclusively developed by each of the Perficio Product Development team members, the training programs have been created to satisfy the growing need in the industry for device-specific education.

All modules are theory/practical based and, through our highly interactive training approach, participants have the opportunity to discuss, deliberate, evaluate and acquire skills and knowledge.

Examples of the training modules we offer are:

  • IVD Medical Device Design and Development
  • Medical Device Design and Development (including regulatory)
  • Risk Management
  • Short course Project Management

The Perficio Product Development trainers will carefully assess your specific needs and tailor the training programs to meet your goals: from brief, overview-type courses for multi-disciplined groups, through to comprehensive and highly detailed programs for small/specialised groups.