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This Medical Device Software V&V course is critical for all software testers, quality engineers, and regulatory professionals  working in the Medical Device and Healthcare industries. Learn the crucial elements of IEC 62304, ISO 14971, 21 CFR § 820.30, FDA General Principles of Software Validation, and other applicable international and regulatory standards as they apply to software testing activities and deliverables.

You will work on a assignments based on a real medical device, designed to help you determine software level of concern, software safety classification, define a software verification & validation plan, and write a software verification & validation summary report. 

Overall, you will learn how to create these types of artifacts while also learning the regulatory requirements and expectations for software used in the medical device industry.

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. Before we begin...

    2. How to use this course

    1. Why Medical Device software is different

      FREE PREVIEW

    2. Types of software requiring validation

    1. Introduction to Regulations, Guidance Documents and International Standards

      FREE PREVIEW

    2. ISO 13485 and software validation

    3. ISO 14971 and software validation

    4. FDA QSR - 21 CFR § 820

    5. FDA QSR - 21 CFR § 820.30 Design Controls

    1. 2023 Guidance, Content of Premarket Submissions for Device Software Functions

    1. IEC 62304 Introduction

    2. IEC 62304 General Requirements

    3. IEC 62304 Introduction to Risk Management

    4. IEC 62304 Software Risk Management Process

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

    6. IEC 62304 Medical Device Software Life Cycle Processes

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

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

    9. IEC 62304 Software Release, Configuration Management Process

    10. IEC 62304 Software Maintenance Process

    11. IEC 62304 Software Problem Resolution Process

    12. IEC 62304, FDA, and PEMS Validation

    13. IEC 62304 Checklist

    1. FDA General Principles of Software Validation Planning

    2. FDA General Principles of Software Validation Requirements

    3. FDA General Principles of Software Validation Design and Coding

    4. FDA General Principles of Software Validation Testing

    5. FDA General Principles of Software Validation Test Coverage

    6. FDA General Principles of Software Validation Maintenance and Anomalies

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

    8. FDA Guidance, Off-The-Shelf Software Use in Medical Devices Introduction

    9. FDA Guidance, OTS Software Documentation Elements

    10. FDA Guidance, OTS Software in Marketing Applications

About this course

  • $595.00
  • 62 lessons
  • 18 hours of video content
  • 11 editable templates
  • 90-day access to course

Software Validation for Medical Devices