[Skip to main content](https://www.ketryx.com/white-papers/discover-why-traceability-doesnt-have-to-be-so-hard#)

White Paper

# Discover Why Traceability Doesn't Have to Be So Hard

Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity.

No items found.

[](https://www.ketryx.com/white-papers/discover-why-traceability-doesnt-have-to-be-so-hard#) [](https://www.ketryx.com/white-papers/discover-why-traceability-doesnt-have-to-be-so-hard#)

Software is the leading cause of medical device recalls.  Heavily regulated products such as safety-critical medical devices require that every step of the development process must be traceable with a rigorous process designed to identify potential risk factors and their contributing conditions.

- Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity.
- Overview of the latest best practices and tools for traceability
- Includes an FDA-approved template and guidance on a more integrated approach to traceability to empower manufacturers to develop better, safer software, faster.

Get the

White Paper

Conversion Page

Landing Page

utm\_campaign

utm\_content

utm\_medium

utm\_source

utm\_term

## More resources

[White Paper\\
\\
**The Cost of Quality**\\
\\
What is quality and why can it make creating products more expensive? What is the cost of creating high quality products?\\
\\
Read more](https://www.ketryx.com/white-papers/the-cost-of-quality)

[White Paper\\
\\
**Regulatory Pathways**\\
\\
Learn about the different approval pathways possible, and how to find the one that works best for you.\\
\\
Read more](https://www.ketryx.com/white-papers/regulatory-pathways)

[White Paper\\
\\
**A Playbook for Transforming Jira to Support IEC 62304 Compliance**\\
\\
To bridge the gap between Jira’s capabilities and IEC 62304 requirements, Ketryx offers integration that extends Jira’s functionality to support compliance. Learn how Ketryx transforms Jira into a powerful tool for IEC 62304-compliant software development. \\
\\
Read more](https://www.ketryx.com/white-papers/a-playbook-for-transforming-jira-to-support-iec-62304-compliance)

[White Paper\\
\\
**IDC Spotlight: Connected Life-Cycle Management Streamlines Software Development for Medical Devices**\\
\\
This Spotlight Paper from leading technology analyst IDC explores how Connected Lifecycle Management (CLM) is transforming software development for regulated industries. \\
\\
Read more](https://www.ketryx.com/white-papers/idc-clm-spotlight-paper)