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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
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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
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Patch Act: How to Comply in 2023 & Beyond

John Koontz
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August 16, 2023
Traceability

The Best RTM Tools for Agile Teams: Looking Beyond Excel

Erez Kaminski
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August 30, 2023
August 9, 2023

2023 FDA Warning Letters and Software Validation

Erez Kaminski
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August 30, 2023
August 9, 2023
Regulations

Clinical Trial Computerized Systems Regulation Review

Jake Stowe
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August 9, 2023
Traceability

The Ultimate Guide to Requirements Traceability Matrix (RTM)

Erez Kaminski
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August 30, 2023
June 19, 2023
Traceability

Ketryx 2.0 Release

Erez Kaminski
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August 30, 2023
May 11, 2023
Regulations

The FDA drops a Cybersecurity Compliance SBOM in 2023

Erez Kaminski
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September 21, 2023
July 19, 2023
Regulations

The Turtle Problem

Jake Stowe
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August 30, 2023
April 13, 2023
Regulations

Why the FDA’s Most Common Warning Letter Might Surprise You

Erez Kaminski
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August 30, 2023
August 24, 2023
Regulations

Key Takeaways from the first Safety-critical Software Meetup in Boston

Erez Kaminski
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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
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August 30, 2023
April 17, 2023
Regulations

SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance

Erez Kaminski
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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?