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This online course focuses on the process of developing software for medical devices. This includes topics such as how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, how to perform software safety classification correctly and working with SOUP/OTS software. The course covers all aspects of the IEC 62304 standard and the relationship between the IEC 62304 and other standards such as ISO 14971, IEC 60601-1 and IEC 82304–1. 

The course include free templates for all required documents, checklist required for showing compliance to the standard and comparison matrix to the FDA standards for developing software in medical device.

Recommended for software managers, software developers, software testers, product managers, regulatory affairs personnel, and quality assurance engineers.

Course Objectives

  • Identify the different types of software regulated by the FDA and interpret the latest FDA regulations, guidelines and International standards applicable to medical device software. 
  • Discuss software level of concern and use it to focus validation activities and develop an appropriate validation strategy. 
  • Explain the different requirements for validation of device, manufacturing & quality system software and discuss how to differentiate between verification and validation in software testing.

Course curriculum

    1. How to use this course

    1. Why Medical Device software is different

    2. IEC 62304 Introduction

    1. IEC 62304 Medical Device Software Life Cycle Processes

    2. IEC 62304 General Requirements

    3. IEC 62304 Software Development Process - Planning and Requirements Analysis

    4. IEC 62304 Software Development Process - Architecture, Detailed Design, Implementation, and Unit Verification

    5. IEC 62304 Software Development Process - Integration Testing and System Testing

    1. IEC 62304 Software Release, Configuration Management Process

    2. IEC 62304 Software Maintenance Process

    3. IEC 62304 Software Problem Resolution Process

    1. IEC 62304 Introduction to Risk Management

    2. IEC 62304 Software Risk Management Process

    1. Off-The-Shelf Software Use in Medical Device - IEC 62304 SOUP

About this course

  • $299.00
  • 19 lessons
  • 4.5 hours of video content
  • 9 editable templates