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FDA
Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx
Paul Jones
•
September 11, 2023
September 12, 2023
Instructions and recommendations for 510K FDA eSTAR submissions
Explore tags
Compliance
FDA
Generative AI
News
Product Development
Quality
Regulatory
Risk Management
Traceability
Update
Validation
Regulations
Ketryx’s guide to DTxEast 2023
•
September 21, 2023
September 14, 2023
FDA
Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx
Paul Jones
•
September 21, 2023
September 12, 2023
Best Practices for Maintaining a Requirement Traceability Matrix in Agile
Jake Stowe
•
September 6, 2023
Regulations
Patch Act: How to Comply in 2023 & Beyond
John Koontz
•
August 30, 2023
August 16, 2023
Traceability
The Best RTM Tools for Agile Teams: Looking Beyond Excel
Erez Kaminski
•
August 30, 2023
August 9, 2023
2023 FDA Warning Letters and Software Validation
Erez Kaminski
•
August 30, 2023
August 9, 2023
Regulations
Clinical Trial Computerized Systems Regulation Review
Jake Stowe
•
September 5, 2023
August 9, 2023
Traceability
The Ultimate Guide to Requirements Traceability Matrix (RTM)
Erez Kaminski
•
August 30, 2023
June 19, 2023
Traceability
Ketryx 2.0 Release
Erez Kaminski
•
August 30, 2023
May 11, 2023
Regulations
The FDA drops a Cybersecurity Compliance SBOM in 2023
Erez Kaminski
•
September 21, 2023
July 19, 2023
Regulations
The Turtle Problem
Jake Stowe
•
August 30, 2023
April 13, 2023
Regulations
Why the FDA’s Most Common Warning Letter Might Surprise You
Erez Kaminski
•
August 30, 2023
August 24, 2023
Regulations
Key Takeaways from the first Safety-critical Software Meetup in Boston
Erez Kaminski
•
August 30, 2023
April 13, 2023
Traceability
A brief overview of cloud security for standard and safety-critical software
John Koontz
•
August 30, 2023
April 17, 2023
Regulations
Computer Software Assurance
Erez Kaminski
•
August 30, 2023
April 17, 2023
Regulations
SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance
Erez Kaminski
•
August 30, 2023
May 12, 2023
AI/ML
Creating FDA-compliant Medical Devices at Lightning Speed with ChatGPT and Ketryx
Felipe Asfura
•
August 30, 2023
April 13, 2023
Regulations
FDA Traceability Matrix Requirements for Medical Devices
Jake Stowe
•
August 30, 2023
May 26, 2023
Discover a new way to develop
regulated software
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?