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$14M to Build the Future of Medical Software
Erez Kaminski
•
December 4, 2023
December 5, 2023
On December 5, 2023, Ketryx announced its Series A funding of $14 million led by Lightspeed Venture Partners with participation from existing investors E14 Fund and Ubiquity Ventures. Company CEO & Founder Erez Kaminski reflects on how we got here and what the investment means for better, safer software—and more of it.
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Product Announcements
Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971
Paul Jones
•
April 19, 2024
Ketryx 2.6
Erez Kaminski
•
April 9, 2024
March 29, 2024
FDA
21 CFR Part 11 Compliance Guide for Jira (Atlassian)
Jake Stowe
•
March 19, 2024
Ketryx 2.5
Erez Kaminski
•
March 30, 2024
February 13, 2024
AI/ML
MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference
Erez Kaminski
•
January 25, 2024
January 25, 2024
$14M to Build the Future of Medical Software
Erez Kaminski
•
January 10, 2024
December 5, 2023
Traceability
IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies
Jan Pöschko
•
March 30, 2024
AI/ML
How to generate an SBOM (Software Bill of Materials) fast
Jan Pöschko
•
March 30, 2024
November 2, 2023
Regulations
Ketryx Guide to RAPS Convergence 2023
Bailey Pearlman
•
October 3, 2023
The latest (June 2023) changes to the FDA’s new premarket submission guidance
Lee Chickering
•
December 4, 2023
October 16, 2023
Regulations
Ketryx’s guide to DTxEast 2023
Bailey Pearlman
•
October 3, 2023
September 14, 2023
FDA
Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx
Paul Jones
•
October 20, 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
•
December 4, 2023
August 16, 2023
Traceability
The Best RTM Tools for Agile Teams: Looking Beyond Excel
Jake Stowe
•
March 30, 2024
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
•
December 4, 2023
August 9, 2023
Traceability
The Ultimate Guide to Requirements Traceability Matrix (RTM)
Jake Stowe
•
March 30, 2024
June 19, 2023
Traceability
Ketryx 2.0 Release
Erez Kaminski
•
December 4, 2023
May 11, 2023
Regulations
The FDA drops a Cybersecurity Compliance SBOM in 2023
Erez Kaminski
•
December 4, 2023
July 19, 2023
Regulations
The Turtle Problem
Jake Stowe
•
December 4, 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
John Koontz
•
March 30, 2024
April 17, 2023
Regulations
SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance
Erez Kaminski
•
December 4, 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
•
February 29, 2024
May 26, 2023
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