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Academy
A Complete Guide to the FDA’s AI/ML Guidance for Medical Devices
Lee Chickering
and
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February 20, 2025
February 20, 2025
Academy
Understanding Software as a Medical Device (SaMD)
Lee Chickering
and
•
February 13, 2025
January 31, 2025
In the News
Why Validated DevOps is the Path Forward for Regulated Software
Erez Kaminski
and
devops.com
•
February 11, 2025
January 30, 2025
News video
Spreadsheet Errors: The Hidden Risk In MedTech
Erez Kaminski
and
Forbes
•
February 11, 2025
January 28, 2025
Academy
FDA Software Verification vs. Validation: What's the Difference?
Lee Chickering
and
•
February 11, 2025
January 27, 2025
Academy
How to Create a Design History File (DHF) for Medical Devices
Lee Chickering
and
•
February 11, 2025
January 15, 2025
Perspectives
Navigating the FDA's New Draft Guidance on AI-Enabled Devices
Jenn Dixon
and
•
February 11, 2025
January 14, 2025
In the News
Transforming Lifecycle Management
Sandra Rodriguez
and
Axendia
•
February 11, 2025
January 10, 2025
In the News
Four Bold Predictions for Medtech in 2025: AI Everywhere, Faster Releases, and Rising Risks
Erez Kaminski
and
MPO News
•
February 11, 2025
December 18, 2024
In the News
Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices
Erez Kaminski
and
Medical Design & Outsourcing
•
February 11, 2025
November 12, 2024
Perspectives
Why So Many Medical Device Companies Lack Real-Time Traceability and Visibility
Jake Stowe
and
•
February 13, 2025
November 12, 2024
In the News
Why The Epidemic In Quality Failures And What MedTechs Can Learn
Erez Kaminski
and
Forbes
•
February 11, 2025
November 8, 2024
Perspectives
How Ketryx Works: Product Design Philosophy and Framework
Jan Pöschko
and
•
February 11, 2025
November 8, 2024
Academy
ISO 14971: A Comprehensive Guide to Risk Management in Medical Devices
Lee Chickering
and
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February 11, 2025
November 7, 2024
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Academy
A Comprehensive Guide to IEC 62304: Navigating the Standard for Medical Device Software
Lee Chickering
and
•
February 11, 2025
October 23, 2024
Academy
Understanding FDA Guidance on AI in Medical Devices and Predetermined Change Control Plans (PCCPs)
Lee Chickering
and
•
February 11, 2025
October 22, 2024
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Perspectives
Should You Change Your Process Before You Update Your Tooling?
Jake Stowe
and
•
February 13, 2025
October 16, 2024
Academy
FDA Cybersecurity Guidance for Medical Devices
Gabriel Pascualy
and
•
February 11, 2025
October 15, 2024
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Academy
Implementing a PCCP & CI/CD for AI/ML-Enabled Medical Devices: A Comprehensive Guide
Lee Chickering
and
•
February 11, 2025
October 11, 2024
Academy
FDA Class II Medical Device Regulations and Compliance
Jenn Dixon
and
•
February 11, 2025
October 3, 2024
Academy
FDA Class I Medical Device Regulations and Compliance
Jenn Dixon
and
•
February 11, 2025
October 2, 2024
Perspectives
From Vision to Validation: The Story Behind Ketryx's Journey to Transforming MedTech Software
Erez Kaminski
and
•
February 11, 2025
October 1, 2024
Academy
Medical Device Software Validation and Verification for Regulatory Compliance
Lee Chickering
and
•
February 11, 2025
September 30, 2024
In the News
How to Survive FDA’s Predetermined Change Control Plan
Erez Kaminski
and
MD+DI
•
February 11, 2025
September 10, 2024
Perspectives
Modernizing the Medical Device Factory to Work With Software
Erez Kaminski
and
•
February 11, 2025
September 4, 2024
In the News
Ketryx Tackles Software Safety in Medical Devices Amid Growing Recalls
Jenna Philpott
and
Medical Device Network
•
February 11, 2025
September 2, 2024
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Perspectives
Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development
Jan Pöschko
and
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February 11, 2025
August 29, 2024
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Perspectives
Beyond the Basics: Building FDA-Compliant SBOMs for MedTech
Gabriel Pascualy
and
•
February 11, 2025
August 8, 2024
Perspectives
How Connected Lifecycle Management Is Revolutionizing MedTech Software Development
Zack Jha
and
•
February 13, 2025
August 5, 2024
Perspectives
Can MedTech Use Validated DevOps to Move as Fast as Netflix?
Erez Kaminski
and
•
February 11, 2025
July 31, 2024
In the News
Medtech compliance — not regulation — is stifling innovation
Erez Kaminski
and
STATNews
•
February 11, 2025
July 26, 2024
In the News
From Recalls to Reliability: Tools to Ensure Software Safety in MedTech
Erez Kaminski
and
MedCity News
•
February 11, 2025
June 14, 2024
Perspectives
FDA Predetermined Change Control Plan (PCCP): Compliance Guide
Lee Chickering
and
•
February 11, 2025
May 9, 2024
In the News
UL Certification: A Launchpad for Product Development Excellence
Erez Kaminski
and
MedTech Intelligence
•
February 11, 2025
May 1, 2024
Perspectives
21 CFR Part 11 Compliance Guide for Jira (Atlassian)
Jake Stowe
and
•
February 11, 2025
April 12, 2024
In the News
Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971
Paul Jones
and
•
February 11, 2025
March 6, 2024
Perspectives
MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference
Erez Kaminski
and
•
February 11, 2025
January 25, 2024
Perspectives
$14M to Build the Future of Medical Software
Erez Kaminski
and
•
February 11, 2025
December 5, 2023
Perspectives
IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies
Jan Pöschko
and
•
February 11, 2025
November 13, 2023
Perspectives
How to generate an SBOM (Software Bill of Materials) fast
Jan Pöschko
and
•
February 11, 2025
November 2, 2023
Perspectives
The latest (June 2023) changes to the FDA’s new premarket submission guidance
Lee Chickering
and
•
February 11, 2025
October 16, 2023
Perspectives
Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx
Paul Jones
and
•
February 11, 2025
September 12, 2023
Perspectives
Best Practices for Maintaining a Requirement Traceability Matrix in Agile
Jake Stowe
and
•
February 11, 2025
September 12, 2023
In the News
Three steps for traceability in medical device software development quality and compliance
Paul Jones
and
Medical Design and Outsourcing
•
February 11, 2025
September 7, 2023
In the News
Q&A: The facts about the PATCH Act
Kiays Khalil
and
Medical Device Network
•
February 11, 2025
September 4, 2023
Perspectives
Why the FDA’s Most Common Warning Letter Might Surprise You
Erez Kaminski
and
•
February 11, 2025
August 24, 2023
Perspectives
PATCH Act: How to Comply in 2023 & Beyond
John Koontz
and
•
February 11, 2025
August 16, 2023
Perspectives
The Best RTM Tools for Agile Teams: Looking Beyond Excel
Jake Stowe
and
•
February 11, 2025
August 9, 2023
Perspectives
Clinical Trial Computerized Systems Regulation Review
Jake Stowe
and
•
February 11, 2025
August 9, 2023
Perspectives
2023 FDA Warning Letters and Software Validation
Erez Kaminski
and
•
February 11, 2025
August 9, 2023
In the News
AI Experts Network: Innovation Labs Series
and
AI Expert Network
•
February 11, 2025
August 4, 2023
In the News
Who pays the bills when AI kills?
Erez Kaminski
and
The Hill
•
February 11, 2025
July 20, 2023
Academy
FDA Cybersecurity SBOM Regulations and Compliance Guide
Erez Kaminski
and
•
February 19, 2025
July 19, 2023
Perspectives
The Ultimate Guide to Requirements Traceability Matrix (RTM)
Jake Stowe
and
•
February 11, 2025
June 19, 2023
In the News
How to Build Safer and More Reliable Software
Erez Kaminski
and
builtin.com
•
February 11, 2025
June 14, 2023
In the News
Medtech Connect Episode 6: The Latest And Greatest In Digital Health Regulations
and
Citeline
•
February 11, 2025
June 9, 2023
In the News
Solving the Systems Interconnectivity Problem
Jake Stowe
and
MD+DI
•
February 11, 2025
June 1, 2023
Perspectives
FDA Traceability Matrix Requirements for Medical Devices
Jake Stowe
and
•
February 11, 2025
May 26, 2023
Perspectives
SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance
Erez Kaminski
and
•
February 11, 2025
May 12, 2023
In the News
How Can Medtechs Prepare for the FDA’s Shift Left Strategy on Cybersecurity?
Erez Kaminski
and
MedCity News
•
February 11, 2025
May 10, 2023
Perspectives
A brief overview of cloud security for standard and safety-critical software
John Koontz
and
•
February 11, 2025
April 17, 2023
Perspectives
Key Takeaways from the first Safety-critical Software Meetup in Boston
Erez Kaminski
and
•
February 11, 2025
April 13, 2023
Regulations
QMS, DHF, DMR and everything in between?
Erez Kaminski
and
•
February 11, 2025
April 13, 2023
Perspectives
Creating FDA-compliant Medical Devices at Lightning Speed with ChatGPT and Ketryx
Felipe Asfura
and
•
February 11, 2025
April 13, 2023
In the News
The Future of Healthcare Is Connected & Data-Driven
Omar Ford
and
mddonline.com
•
February 11, 2025
November 30, 2022
In the News
MIT Media Lab Spring Meeting 2022: E14 Startups
Sarah Beckmann
and
media.mit.edu
•
February 11, 2025
April 6, 2022
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