Implementing Iec 62304 In Software As A Medical Device

Best Practices for Compliance and Safety in Medical Device Software

What you'll learn

Understand and Apply IEC 62304 in Medical Device Software Development

Classify Software According to Risk and Ensure Compliance with Safety Requirements

Integrate Risk Management into the Software Development Process

Implement Best Practices for Verification, Validation, and Configuration Management

Utilize JIRA and Confluence for Documentation

Requirements

Basic Understanding of Software Development-Learners should have a general knowledge of software development principles (e.g., familiarity with coding, development cycles, or experience working in software projects).

Familiarity with Quality Management or Regulatory Compliance-A general understanding of quality management practices (such as ISO standards or FDA regulations) would benefit learners, especially those working in regulated industries.

Experience or Interest in the Medical Device Industry (Optional but Beneficial)-While not required, learners with experience in medical devices or interest in medical software will find the content more directly applicable to their work

Access to JIRA and Confluence (Optional) -Although not mandatory, learners might benefit from having access to these tools to follow along with examples and exercises.

Description

Are you ready to navigate the complex world of medical device software development with confidence? In this course, you'll learn how to successfully implement IEC 62304, the global standard for medical device software, ensuring your products meet regulatory requirements while prioritizing safety and compliance. Discover the best practices, tools, and strategies to manage risk, track software changes, and streamline your development process. Whether you're a software engineer, QA professional, or project manager, this course will equip you with the skills and knowledge to build compliant, high-quality medical software that passes audits with ease.In addition to mastering IEC 62304, this course also integrates the use of Atlassian tools such as Confluence and JIRA, essential for effective project management and documentation. You’ll learn how to leverage JIRA for ISO14971 Risk management process, and ensuring traceability throughout the software lifecycle. Confluence will be utilized for creating comprehensive documentation, collaboration, and maintaining a clear audit trail, all vital for regulatory compliance. With practical insights and real-world examples, you’ll explore risk management techniques, documentation processes, and verification methods that align with IEC 62304. By the end of this course, you’ll confidently lead your team using best practices to deliver safe, compliant medical device software.

Overview

Section 1: Introduction

Lecture 1 Introduction

Section 2: What is IEC 62304

Lecture 2 What is IEC 62304

Section 3: Introduction to Confluence and its Role in Medical Documentation

Lecture 3 Introduction to Confluence and Its Role in Medical Documentation

Section 4: Software Safety Classification

Lecture 4 Software Safety Classification

Section 5: Software Development Process

Lecture 5 Software Development Process- Planning

Lecture 6 Software Development Process- Software Requirement Analysis

Lecture 7 Software Development Process- Software Architectural Design

Lecture 8 Software Development Process- Detailed Design Specifications

Lecture 9 Software Development Process-Software unit implementation and verification

Lecture 10 Software Development Process-Software integration and integration test

Lecture 11 Software Development Process-Software System testing

Lecture 12 Software Development Process-Software release

Section 6: Software Maintenance

Lecture 13 Software Maintenance

Section 7: Risk Management

Lecture 14 Risk Management

Section 8: Software configuration management

Lecture 15 Software configuration management

Section 9: Problem Resolution Process

Lecture 16 Problem Resolution Process

Software Developers – working in medical device software development, especially those new to IEC 62304 or looking to enhance their knowledge,Quality Assurance Professionals – responsible for ensuring compliance with medical device regulations,Project Managers – overseeing software development projects and ensuring they meet regulatory standards,Regulatory and Compliance Officers – working in the medical device industry, needing to understand the key requirements for software development,Students or Recent Graduates – interested in entering the medical device software industry and need a foundation in regulatory requirements