IVD Medical Device Design and Development

In-Vitro Diagnostic (IVD) Design and Development is a two day course intended for those involved in IVD development and who wish to have an enhanced understanding of the overarching regulatory frameworks of the USA and EU.  In particular, this course examines ISO 13475:2003 Medical Devices - Quality management systems for regulatory purposes, section 7.3 Product Realisation.

Course Overview

The IVD Design and Development training course presents the fundamental principles underpinning the different regulatory systems of the USA and the EU.  The course presents the requirements of ISO 13485: Section 7.3 Product Realisation and techniques for meeting these requirements.  The course also presents a comparison of ISO 13484 and 21 CRF 820.  Several concepts are presented including the "concentric rings of system verification and validation" and the "golden eggs" of management know-how required to underpin mainstream engineering activites.

Who Should Attend

The course is aimed at:

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

Course Outline

Day 1 -  (9:00am to 4:30pm)      

INTRODUCTION

FDA Regulatory Overview

  • Explanation of 21 CFR Part 800 Series
  • Explanation of teh GEneral Controls, Special Control and PMA approach to IVD safety and efficacy for each risk class
  • Explanation of IVD classification and approval pathways for 510(k) Exempt, 510(k) and PMA approvals
  • Explanation of General and Special Controls
  • Explanation of the IDE process 

EU/Australia Regulatory Overview

  • Explanation of the IVDMD Directive 98/79/EC and EU regulatory frameworks
  • Explanation of the essential requirements and harmonized standards
  • Explanation of the risk based classification of IVDs
  • Explanation of the conformity assessment processes and pathways.

ISO 13485 SECTION 7.3 DESIGN AND DEVELOPMENT

ISO 13485 Section 7.3.1 Design and Development Planning

  • Introduction of PMBOK model of project management and its application to the requirements of 7.3.1 of the standard
  • Provide FDA warning letter example

ISO 13485 Section 7.3.2 Design Inputs

  • Slide presentation and interactive discussion showing:
    • the role of 'requirements' in the V structure of product development
    • the types of requirements
    • the essential requirements
  • Interactive development of the product requirements for the 'Avian Influenza IVD'
  • Interactive development of the system requirements for the 'Avian Influenza IVD'
  • Discuss FDA warning letter re 'Design Inputs'
  • Design Inputs from Risk Analysis
  • Sample hazards analysis provided with risk mitigation example listed in product requirements

Day 2 -  (9:00am to 4:30pm)

ISO 13485 Section 7.3.3 Design Outputs

  • Slide presentation and interactive discussion showing:
    • Design History File
    • Device Master Record
    • establishing traceability
    • type of information in DHR and DMR
    • FDA warning letter

 

ISO 13495 Section 7.3.4 Design and Development Review

  • Slide presentation and interactive discussion relating to:
    • types of review
    • introduction to configuration management
    • Document Review and role of the review leader 
  • Interactive peer review of the Perficio Product Development Document Review Work Instruction
  • Review of FDA warning letter
  • Introduce Issue Management

ISO 13485 Section 7.3.5 Design Verification

  • Slide presentation and interactive discussion relating to:
    • What is verification?
    • What is validation?  
  • Introduce verification and validation planning process templates
  • Introduce CLSI standards
  • Introduce test method protocols and method validation
  • Introduce verification summary structure
  • Provide FDA warning letter examples 

ISO 13485 Section 7.3.6 Design Validation

  • Introduce design validation models
  • Introduce design validation planning 
  • Slide presentation and interactive discussion relating to:
    • types of validation testing
    • clinical validation

 ISO 13485 Section 7.3.7 Change Control

  • Introduce change control process
  • Introduce configuration management
  • Slide presentation and interactive discussioin relating to:
    • what is change control?
    • the Form Fit and Function rule
    • effects of change 

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:

  • Medical Device Design and Development (including regulatory)
  • Medical Device Design and Development (including risk management)
  • 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.