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Free Download Implementing Iec 62304 In Software As A Medical Device Published 9/2024 MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz Language: English | Size: 1009.08 MB | Duration: 2h 44m 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 Homepage https://www.udemy.com/course/implementing-iec-62304-in-software-as-a-medical-device/ Rapidgator https://rg.to/file/4912baa1b1704bd93628673c091fa63d/ukypf.Implementing.Iec.62304.In.Software.As.A.Medical.Device.part1.rar.html https://rg.to/file/d845e8188e52c9e6c314f5452ad88a2c/ukypf.Implementing.Iec.62304.In.Software.As.A.Medical.Device.part2.rar.html Fikper Free Download https://fikper.com/Mdc7k1QAA1/ukypf.Implementing.Iec.62304.In.Software.As.A.Medical.Device.part1.rar.html https://fikper.com/GhW0Glir5G/ukypf.Implementing.Iec.62304.In.Software.As.A.Medical.Device.part2.rar.html No Password - Links are Interchangeable