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Live Webinar Oct 11: Using a risk-based approach to comply with FDA's 21 CFR Part 11
What is Ketryx?
Connected Lifecycle Management platform for regulated medical applications
QA / RA
Dev / R&D
Regulated Development Resources
FDA software regulations and compliance education designed for developers, builders, and software quality professionals
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.
Learn about the different approval pathways possible, and how to find the one that works best for you
IEC 62304 Compliance Checklist
Companies can take a few key steps to simplify their FDA compliance journey and start building medical software. Use this checklist to go through these key steps.
SaMD Regulatory Requirements
Learn which regulations and standards are necessary to meet compliance
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?
Inside the FDA Regulatory Process
Former FDA software systems safety expert, Paul Jones, shares his insights.
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Creating and managing the lifecycle of a medical application is expensive, time-consuming, and error-prone. But what if it didn't need to be?