Medical Device & Life Sciences Development
The Essential Guide to Requirements Management and Traceability
Chapters
- 1. Requirements Management
- Overview
- 1 What is Requirements Management?
- 2 Why do you need Requirements Management?
- 3 Four Stages of Requirements Management Processes
- 4 Adopting an Agile Approach to Requirements Management
- 5 Status Request Changes
- 6 Conquering the 5 Biggest Challenges of Requirements Management
- 7 Three Reasons You Need a Requirements Management Solution
- 8 Guide to Poor Requirements: Identify Causes, Repercussions, and How to Fix Them
- 2. Writing Requirements
- Overview
- 1 Functional requirements examples and templates
- 2 Identifying and Measuring Requirements Quality
- 3 How to write system requirement specification (SRS) documents
- 4 The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence
- 5 Adopting the EARS Notation to Improve Requirements Engineering
- 6 Jama Connect Advisor™
- 7 Frequently Asked Questions about the EARS Notation and Jama Connect Advisor™
- 8 How to Write an Effective Product Requirements Document (PRD)
- 9 Functional vs. Non-Functional Requirements
- 10 What Are Nonfunctional Requirements and How Do They Impact Product Development?
- 11 Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)
- 12 8 Do’s and Don’ts for Writing Requirements
- 3. Requirements Gathering and Management Processes
- Overview
- 1 Requirements Engineering
- 2 Requirements Analysis
- 3 A Guide to Requirements Elicitation for Product Teams
- 4 Requirements Gathering Techniques for Agile Product Teams
- 5 What is Requirements Gathering?
- 6 Defining and Implementing a Requirements Baseline
- 7 Managing Project Scope — Why It Matters and Best Practices
- 8 How Long Do Requirements Take?
- 9 How to Reuse Requirements Across Multiple Products
- 4. Requirements Traceability
- Overview
- 1 What is Traceability?
- 2 How is Traceability Achieved? A Practical Guide for Engineers
- 3 Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development
- 4 Change Impact Analysis (CIA): A Short Guide for Effective Implementation
- 5 What is Requirements Traceability and Why Does It Matter for Product Teams?
- 6 What is Meant by Version Control?
- 7 Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency
- 8 Unraveling the Digital Thread: Enhancing Connectivity and Efficiency
- 9 The Role of a Data Thread in Product and Software Development
- 10 How to Create and Use a Requirements Traceability Matrix
- 11 Traceability Matrix 101: Why It’s Not the Ultimate Solution for Managing Requirements
- 12 Live Traceability vs. After-the-Fact Traceability
- 13 How to Overcome Organizational Barriers to Live Requirements Traceability
- 14 Requirements Traceability, What Are You Missing?
- 15 Four Best Practices for Requirements Traceability
- 16 Requirements Traceability: Links in the Chain
- 17 What Are the Benefits of End-to-End Traceability During Product Development?
- 5. Requirements Management Tools and Software
- Overview
- 1 Selecting the Right Requirements Management Tools and Software
- 2 Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn
- 3 Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development
- 4 Application lifecycle management (ALM)
- 5 Is There Life After DOORS®?
- 6 Can You Track Requirements in Jira?
- 7 Checklist: Selecting a Requirements Management Tool
- 6. Requirements Validation and Verification
- 7. Meeting Regulatory Compliance and Industry Standards
- Overview
- 1 Understanding ISO Standards
- 2 Understanding ISO/IEC 27001: A Guide to Information Security Management
- 3 What is DevSecOps? A Guide to Building Secure Software
- 4 Compliance Management
- 5 What is FMEA? Failure Modes and Effects Analysis
- 6 TÜV SÜD: Ensuring Safety, Quality, and Sustainability Worldwide
- 8. Systems Engineering
- Overview
- 1 What is Systems Engineering?
- 2 How Do Engineers Collaborate? A Guide to Streamlined Teamwork and Innovation
- 3 The Systems Engineering Body of Knowledge (SEBoK)
- 4 What is MBSE? Model-Based Systems Engineering Explained
- 5 Digital Engineering Between Government and Contractors
- 6 Digital Engineering Tools: The Key to Driving Innovation and Efficiency in Complex Systems
- 9. Automotive Development
- 10. Medical Device & Life Sciences Development
- Overview
- 1 The Importance of Benefit-Risk Analysis in Medical Device Development
- 2 Software as a Medical Device: Revolutionizing Healthcare
- 3 What’s a Design History File, and How Are DHFs Used by Product Teams?
- 4 Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device & Life Sciences Industry
- 5 What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing
- 6 What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security
- 7 ISO 13485 vs ISO 9001: Understanding the Differences and Synergies
- 8 Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know
- 9 Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)
- 11. Aerospace & Defense Development
- 12. Architecture, Engineering, and Construction (AEC industry) Development
- 13. Industrial Manufacturing & Machinery, Automation & Robotics, Consumer Electronics, and Energy
- 14. Semiconductor Development
- 15. AI in Product Development
- Glossary
Chapters
- 1. Requirements Management
- Overview
- 1 What is Requirements Management?
- 2 Why do you need Requirements Management?
- 3 Four Stages of Requirements Management Processes
- 4 Adopting an Agile Approach to Requirements Management
- 5 Status Request Changes
- 6 Conquering the 5 Biggest Challenges of Requirements Management
- 7 Three Reasons You Need a Requirements Management Solution
- 8 Guide to Poor Requirements: Identify Causes, Repercussions, and How to Fix Them
- 2. Writing Requirements
- Overview
- 1 Functional requirements examples and templates
- 2 Identifying and Measuring Requirements Quality
- 3 How to write system requirement specification (SRS) documents
- 4 The Fundamentals of Business Requirements: Examples of Business Requirements and the Importance of Excellence
- 5 Adopting the EARS Notation to Improve Requirements Engineering
- 6 Jama Connect Advisor™
- 7 Frequently Asked Questions about the EARS Notation and Jama Connect Advisor™
- 8 How to Write an Effective Product Requirements Document (PRD)
- 9 Functional vs. Non-Functional Requirements
- 10 What Are Nonfunctional Requirements and How Do They Impact Product Development?
- 11 Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)
- 12 8 Do’s and Don’ts for Writing Requirements
- 3. Requirements Gathering and Management Processes
- Overview
- 1 Requirements Engineering
- 2 Requirements Analysis
- 3 A Guide to Requirements Elicitation for Product Teams
- 4 Requirements Gathering Techniques for Agile Product Teams
- 5 What is Requirements Gathering?
- 6 Defining and Implementing a Requirements Baseline
- 7 Managing Project Scope — Why It Matters and Best Practices
- 8 How Long Do Requirements Take?
- 9 How to Reuse Requirements Across Multiple Products
- 4. Requirements Traceability
- Overview
- 1 What is Traceability?
- 2 How is Traceability Achieved? A Practical Guide for Engineers
- 3 Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development
- 4 Change Impact Analysis (CIA): A Short Guide for Effective Implementation
- 5 What is Requirements Traceability and Why Does It Matter for Product Teams?
- 6 What is Meant by Version Control?
- 7 Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency
- 8 Unraveling the Digital Thread: Enhancing Connectivity and Efficiency
- 9 The Role of a Data Thread in Product and Software Development
- 10 How to Create and Use a Requirements Traceability Matrix
- 11 Traceability Matrix 101: Why It’s Not the Ultimate Solution for Managing Requirements
- 12 Live Traceability vs. After-the-Fact Traceability
- 13 How to Overcome Organizational Barriers to Live Requirements Traceability
- 14 Requirements Traceability, What Are You Missing?
- 15 Four Best Practices for Requirements Traceability
- 16 Requirements Traceability: Links in the Chain
- 17 What Are the Benefits of End-to-End Traceability During Product Development?
- 5. Requirements Management Tools and Software
- Overview
- 1 Selecting the Right Requirements Management Tools and Software
- 2 Why Investing in Requirements Management Software Makes Business Sense During an Economic Downturn
- 3 Why Word and Excel Alone is Not Enough for Product, Software, and Systems Development
- 4 Application lifecycle management (ALM)
- 5 Is There Life After DOORS®?
- 6 Can You Track Requirements in Jira?
- 7 Checklist: Selecting a Requirements Management Tool
- 6. Requirements Validation and Verification
- 7. Meeting Regulatory Compliance and Industry Standards
- Overview
- 1 Understanding ISO Standards
- 2 Understanding ISO/IEC 27001: A Guide to Information Security Management
- 3 What is DevSecOps? A Guide to Building Secure Software
- 4 Compliance Management
- 5 What is FMEA? Failure Modes and Effects Analysis
- 6 TÜV SÜD: Ensuring Safety, Quality, and Sustainability Worldwide
- 8. Systems Engineering
- Overview
- 1 What is Systems Engineering?
- 2 How Do Engineers Collaborate? A Guide to Streamlined Teamwork and Innovation
- 3 The Systems Engineering Body of Knowledge (SEBoK)
- 4 What is MBSE? Model-Based Systems Engineering Explained
- 5 Digital Engineering Between Government and Contractors
- 6 Digital Engineering Tools: The Key to Driving Innovation and Efficiency in Complex Systems
- 9. Automotive Development
- 10. Medical Device & Life Sciences Development
- Overview
- 1 The Importance of Benefit-Risk Analysis in Medical Device Development
- 2 Software as a Medical Device: Revolutionizing Healthcare
- 3 What’s a Design History File, and How Are DHFs Used by Product Teams?
- 4 Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device & Life Sciences Industry
- 5 What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing
- 6 What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security
- 7 ISO 13485 vs ISO 9001: Understanding the Differences and Synergies
- 8 Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know
- 9 Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)
- 11. Aerospace & Defense Development
- 12. Architecture, Engineering, and Construction (AEC industry) Development
- 13. Industrial Manufacturing & Machinery, Automation & Robotics, Consumer Electronics, and Energy
- 14. Semiconductor Development
- 15. AI in Product Development
- Glossary
Medical Device & Life Sciences Development
Unlock the Path to Medical Device & Life Sciences Excellence!
In this chapter, we are focused on medical device & life sciences development. Read more to learn more about:
Best Practices for Success: Gain invaluable insights into the best practices employed by industry leaders in medical device and life sciences development. Explore proven methodologies, innovative approaches, and strategic frameworks that drive success in this highly regulated and rapidly evolving field. From concept to commercialization, empower yourself with the knowledge to overcome challenges and achieve optimal outcomes.
Navigating Regulatory Standards: Navigate the complex landscape of regulatory standards with confidence. Stay up to date with the latest guidelines, compliance requirements, and quality management systems necessary for medical device and life sciences development. Our educational resources provide a comprehensive understanding of regulatory frameworks, including FDA regulations, ISO standards, and global harmonization guidelines. Ensure your products meet the highest safety and quality standards, while expediting the regulatory approval process.
Thought Leadership and Innovation: Tap into the minds of thought leaders and visionaries shaping the future of medical device and life sciences industries. Learn from renowned experts who share their industry insights, research breakthroughs, and emerging trends. Stay at the forefront of technological advancements, such as digital health, artificial intelligence, and personalized medicine. Discover the transformative power of innovation and explore how it drives the next generation of medical devices and life sciences solutions.
In this Chapter:
10.1 – The Importance of Benefit-Risk Analysis in Medical Device Development
10.2 – Software as a Medical Device: Revolutionizing Healthcare
10.3 – What’s a Design History File, and How Are DHFs Used by Product Teams?
10.4 – Navigating the Risks of Software of Unknown Pedigree (SOUP) in the Medical Device & Life Sciences Industry
10.5 – What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing
10.6 – What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security
10.7 – ISO 13485 vs ISO 9001: Understanding the Differences and Synergies
10.8 – Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know
10.9 – Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)
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