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Traceability
Why So Many Medical Device Companies Lack Real-Time Traceability and Visibility
Jake Stowe
•
November 12, 2024
November 12, 2024
Product Announcements
How Ketryx Works: Product Design Philosophy and Framework
Jan Pöschko
•
November 8, 2024
November 8, 2024
FDA
ISO 14971: A Comprehensive Guide to Risk Management in Medical Devices
Ketryx
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November 7, 2024
November 7, 2024
AI/ML
A Complete Guide to the FDA’s AI/ML Guidance for Medical Devices
Ketryx
•
October 24, 2024
October 24, 2024
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Regulations
A Comprehensive Guide to IEC 62304: Navigating the Standard for Medical Device Software
Ketryx
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October 23, 2024
October 23, 2024
FDA
Understanding FDA Guidance on AI in Medical Devices and Predetermined Change Control Plans (PCCPs)
Ketryx
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November 11, 2024
October 22, 2024
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Should You Change Your Process Before You Update Your Tooling?
Jake Stowe
•
November 7, 2024
October 16, 2024
FDA
FDA Cybersecurity Guidance for Medical Devices
Gabriel Pascualy
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November 12, 2024
October 15, 2024
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AI/ML
Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices: A Comprehensive Guide
Ketryx
•
October 11, 2024
October 11, 2024
From Vision to Validation: The Story Behind Ketryx's Journey to Transforming MedTech Software
Erez Kaminski
•
November 11, 2024
October 1, 2024
FDA
Medical Device Software Validation and Verification for Regulatory Compliance
Ketryx
•
September 30, 2024
September 30, 2024
How to Survive FDA’s Predetermined Change Control Plan
Erez Kaminski
MD+DI
•
October 23, 2024
September 10, 2024
Traceability
Modernizing the Medical Device Factory to Work With Software
Erez Kaminski
•
October 3, 2024
September 4, 2024
Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls
Jenna Philpott
Medical Device Network
•
October 23, 2024
September 2, 2024
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Regulations
Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development
Jan Pöschko
•
October 3, 2024
August 29, 2024
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FDA
Beyond the Basics: Building FDA-Compliant SBOMs for MedTech
Gabriel Pascualy
•
November 12, 2024
August 8, 2024
How Connected Lifecycle Management Is Revolutionizing MedTech Software Development
Zack Jha
•
October 3, 2024
August 5, 2024
Can MedTech Use Validated DevOps to Move as Fast as Netflix?
Erez Kaminski
•
October 3, 2024
July 31, 2024
In the News
Medtech compliance — not regulation — is stifling innovation
Erez Kaminski
STATNews
•
October 22, 2024
July 26, 2024
From Recalls to Reliability: Tools to Ensure Software Safety in MedTech
Erez Kaminski
MedCity News
•
November 12, 2024
June 14, 2024
FDA Predetermined Change Control Plan (PCCP): Compliance Guide
Lee Chickering
•
November 12, 2024
May 9, 2024
UL Certification: A Launchpad for Product Development Excellence
Erez Kaminski
MedTech Intelligence
•
October 23, 2024
May 1, 2024
Product Announcements
Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971
Paul Jones
•
November 12, 2024
March 6, 2024
AI/ML
MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference
Erez Kaminski
•
November 12, 2024
January 25, 2024
Traceability
IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies
Jan Pöschko
•
November 12, 2024
November 13, 2023
AI/ML
How to generate an SBOM (Software Bill of Materials) fast
Jan Pöschko
•
October 3, 2024
November 2, 2023
The latest (June 2023) changes to the FDA’s new premarket submission guidance
Lee Chickering
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October 3, 2024
October 16, 2023
Best Practices for Maintaining a Requirement Traceability Matrix in Agile
Jake Stowe
•
November 12, 2024
September 12, 2023
FDA
Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx
Paul Jones
•
October 3, 2024
September 12, 2023
Three steps for traceability in medical device software development quality and compliance
Paul Jones
Medical Design and Outsourcing
•
October 23, 2024
September 7, 2023
Q&A: The facts about the PATCH Act
Kiays Khalil
Medical Device Network
•
October 23, 2024
September 4, 2023
Regulations
Why the FDA’s Most Common Warning Letter Might Surprise You
Erez Kaminski
•
October 3, 2024
August 24, 2023
Regulations
Clinical Trial Computerized Systems Regulation Review
Jake Stowe
•
October 3, 2024
August 9, 2023
Traceability
The Best RTM Tools for Agile Teams: Looking Beyond Excel
Jake Stowe
•
October 3, 2024
August 9, 2023
Regulations
The FDA drops a Cybersecurity Compliance SBOM in 2023
Erez Kaminski
•
November 12, 2024
July 19, 2023
Traceability
The Ultimate Guide to Requirements Traceability Matrix (RTM)
Jake Stowe
•
October 3, 2024
June 19, 2023
How to Build Safer and More Reliable Software
Erez Kaminski
builtin.com
•
October 23, 2024
June 14, 2023
Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations
Citeline
•
October 23, 2024
June 9, 2023
Regulations
FDA Traceability Matrix Requirements for Medical Devices
Jake Stowe
•
October 3, 2024
May 26, 2023
Regulations
SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance
Erez Kaminski
•
November 12, 2024
May 12, 2023
How Can Medtechs Prepare for the FDA’s Shift Left Strategy on Cybersecurity?
Erez Kaminski
MedCity News
•
October 23, 2024
May 10, 2023
Traceability
A brief overview of cloud security for standard and safety-critical software
John Koontz
•
October 3, 2024
April 17, 2023
AI/ML
Creating FDA-compliant Medical Devices at Lightning Speed with ChatGPT and Ketryx
Felipe Asfura
•
October 3, 2024
April 13, 2023
Regulations
Key Takeaways from the first Safety-critical Software Meetup in Boston
Erez Kaminski
•
October 3, 2024
April 13, 2023
The Future of Healthcare Is Connected & Data-Driven
Omar Ford
mddonline.com
•
October 23, 2024
November 30, 2022
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