jama-logo-primary
  • Product
    • JAMA CONNECT®
      • Product Overview
      • Features
      • Integrations
      • Pricing and Licensing
      • Why Jama Software?
      • Trial
    • Customer Success
      • Success Programs
      • Support
      • Community
  • Solutions
    • Solution by Industry
      • Aerospace and Defense
      • Automotive
      • Software Development
      • Financial Services and Insurance
      • Government
      • Industrial Manufacturing
      • Medical Device & Life Sciences
      • Semiconductor
    • Solution by Function
      • Requirements Management
      • Requirements Traceability
      • Risk Management
      • Test Management
      • MBSE
    • Compare
      • codebeamer
      • IBM® DOORS®
      • DOORS® Next®
      • Jira® Software
      • Polarion
  • Company
    • Company Information
      • About Us
      • Leadership
      • Careers
      • Requirements Traceability Alliance
      • Partners
      • Customers
      • Contact Us
    • News and Events
      • Events
      • Press Room
  • Resources
    • Content Library
    • Guide to Requirements Management and Traceability
    • Discovery Center
    • Customer Stories
    • Webinars
    • Product Demos
    • Support
    • Community
  • Blog
  • Get Started
  • Search
  • Menu Menu
Follow a manual added link
Follow a manual added link

The Essential Guide to Requirements Management and Traceability

Follow a manual added link

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 Fundamentals of Requirements Management
    • 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
  • 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 Adopting the EARS Notation to Improve Requirements Engineering
    • 5 Jama Connect Advisor™
    • 6 Frequently Asked Questions about the EARS Notation and Jama Connect Requirements Advisor
    • 7 How to Write an Effective Product Requirements Document (PRD)
    • 8 Functional vs. Non-Functional Requirements
    • 9 What Are Non-Functional Requirements and How Do They Impact Product Development?
    • 10 Characteristics of Effective Software Requirements and Software Requirements Specifications (SRS)
    • 11 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?
  • 4. Requirements Traceability
    • Overview
    • 1 What is Traceability?
    • 2 Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development
    • 3 Change Impact Analysis (CIA): A Short Guide for Effective Implementation
    • 4 What is Requirements Traceability and Why Does It Matter for Product Teams?
    • 5 Key Traceability Challenges and Tips for Ensuring Accountability and Efficiency
    • 6 How to Create and Use a Requirements Traceability Matrix
    • 7 Traceability Matrix 101: Why It’s Not the Ultimate Solution for Managing Requirements
    • 8 Live Traceability vs. After-the-Fact Traceability
    • 9 How to Overcome Organizational Barriers to Live Requirements Traceability
    • 10 Requirements Traceability, What Are You Missing?
    • 11 Four Best Practices for Requirements Traceability
    • 12 Requirements Traceability: Links in the Chain
    • 13 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 Application lifecycle management (ALM)
    • 4 Is There Life After DOORS®? 
    • 5 Checklist: Selecting a Requirements Management Tool
  • 6. Requirements Validation and Verification
    • Overview
    • 1 Requirements Verification and Validation for Product Teams
    • 2 Best Practices for Verification and Validation in Product Development
  • 7. Meeting Regulatory Compliance and Industry Standards
    • Overview
    • 1 Understanding ISO Standards
    • 2 What is DevSecOps? A Guide to Building Secure Software
    • 3 Compliance Management
    • 4 What is FMEA? Failure Modes and Effects Analysis
  • 8. Systems Engineering
    • Overview
    • 1 What is Systems Engineering?
    • 2 The Systems Engineering Body of Knowledge (SEBoK)
    • 3 What is MBSE? Model-Based Systems Engineering Explained
    • 4 Digital Engineering Between Government and Contractors
  • 9. Automotive Development
    • Overview
    • 1 ISO 26262 and Recent Updates: Ensuring Functional Safety in the Automotive Industry
    • 2 A Guide to Automotive Safety Integrity Levels (ASIL)
  • 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 What is ISO 13485? Your Comprehensive Guide to Compliant Medical Device Manufacturing
    • 5 Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know
    • 6 Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)
  • 11. Aerospace & Defense Development
    • Overview
    • 1 ARP4754A / ED-79A: Enhancing Safety in Aviation 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.

Ready to Find Out More?

Our team of experts is here to answer any questions and learn how we can help enable your continued success. Get started by filling out this form so we can connect!

CONTACT US
Next Up: What’s a Design History File, and How Are DHFs Used by Product Teams?
Previous: A Guide to Automotive Safety Integrity Levels (ASIL)

CONNECT WITH US

  • Facebook
  • LinkedIn
  • Twitter
  • Youtube

USA
135 SW Taylor Suite 200
Portland, Oregon, 97204

EUROPE
Amsterdam Queens Tower
Delflandlaan 1, 1062EA Amsterdam
The Netherlands

© 2023 Jama Software

  • JAMA CONNECT
  • Product Overview
  • Pricing and Licensing
  • Success Programs
  • Trial
  • COMPANY
  • About Us
  • Careers
  • Customers
  • Press Room
  • Contact Us
  • RESOURCES
  • Resource Library
  • Events
  • Press Room
  • Blog
  • Success Programs
  • User Community
  • Support
  • Privacy Policy
  • Cookies
  • Privacy and Security
  • Legal
  • Preferences
Scroll to top