Software Development for Medical Device Manufacturers

Course Description:
Developing software in compliance with FDA, EU regulations and international standards is challenging. This two-day intensive course provides practical guidance and suggestions for developing software that complies with applicable FDA and EU regulations, recent guidance documents and international standards such as IEC 62304 and ISO 14971. The focus of this course is interpreting Design Controls for software. Each section of the Design Controls regulation (820.30) is discussed from the software perspective. Corresponding requirements from IEC 62304 are woven into the flow. In-depth discussion of critical topics such as Requirements, Software Verification & Validation, Risk Management and Fault Tree Analysis are included. In addition, techniques for validating software development tools and software used in Manufacturing and Quality Systems are also discussed. Interactive group exercises are included to facilitate discussion and learning.

Who Should Attend:
This course is intended for:

  • Software engineers
  • Software managers
  • Project managers
  • Software validation staff
  • RA/QA staff

Day 1 Topics
Introduction to Medical Device Software

  • FDA Regulations and Guidance Documents
  • EU Medical Device Regulations
  • International Standards
  • Types of Software Regulated by FDA
  • Examples of Software Procedures, Work Instructions and Records
  • ALL Software is Defective

Interpreting Design Controls for Software

  • General Requirements
  • Design and Development Planning
    Software Development Models…
  • Design Input
    About Requirements…
    Requirements Exercise
  • Design Output
  • Design Reviews
    Types of Design Reviews
  • Design Verification
    Unit and Integration Testing
    Static Analysis
  • Design Validation
    Testing Overview
    Software Validation Planning
    Validation Exercise
  • Design Changes
  • Design Transfer
  • Design History File
  • Document and Data Control

Day 2 Topics
Validation of…

  • Software Development Tools
  • Software Used in Manufacturing and Production
  • Software Used in Quality Systems

Risk Management

  • Term and Concepts
  • Specific Software Issues
  • Risk Management Overview
  • Risk Assessment
  • Risk Control
  • Tools – Fault Tree Analysis and FMECA
  • Risk Management Exercise
  • Production and Post-production Data Collection
  • Documentation Requirements

Outcomes / Course Objectives:
Upon completion of this course, attendees will:

  • Understand the regulatory roadmap for different classes of devices in both the US and EU
  • Become familiar with software-related FDA guidance documents
  • Understand how to interpret FDA Design Controls and IEC 62304 requirements for medical device software
  • Learn techniques for expressing software requirements in a manner that is non-ambiguous and verifiable
  • Learn techniques for validating software development tools, software used in manufacturing, and software used as part of QMS
  • Understand risk management requirements and learn how fault tree analysis and FMECAs can be used as part of the risk management process

Course instructor: Steven Rakitin – Consultant, Software Engineering

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