J. David Giese

CEO & CO-FOUNDER

Joined: January 1, 2012

Skills

Regulatory Strategy Software Engineering Writing

Bio

I live in New York City with my wife and daughter. I’m a biomedical engineer, a software developer, and now a run a Innolitics with Yujan, my old friend and business partner.

Hobbies

I enjoy reading, thinking, and writing about classic literature, philosophy, history, and religion. I see these activities as ends in and of themselves, however, I'm especially interested in how to apply their wisdom as a means to living the good life. My personal website is goodlifeodyssey.com.

Articles by J. David Giese

Is your 510(k) having a “Babel” moment?
Can Your Software Diagrams Slow Down Your FDA Submission?
FDA Pre-Subs: Best Practices, FAQs, and Examples
Draft FDA Generative AI Guidance
How to Avoid $100k AI/ML Mistake
To Rewrite or Not: From Prototype to FDA-Compliant Software
Medical Device SBOMs: Best Practices, FAQs, and Examples
Off-The-Shelf Software: Best Practices, FAQs, and Examples
Medical Device Cybersecurity: Best Practices, FAQs, and Examples
Medical-Device Software Regulations: Best Practices, FAQs, and Examples
Digital Therapeutics: Best Practices, FAQs, and Examples
Why Are you Wasting Time Building Your Medical Device?
2023 Final FDA Cybersecurity Guidance - Redline
How Frequently Can you Release Medical Device Software?
Get to Market Faster with Software-Savvy Regulatory Experts
The Ultimate 510(k) Checklist
“It’s the Workflow, Stupid” - Lessons Learned Bringing Radiology AI/ML to Market
Powerful Debugging Techniques: A Real-World Example
Striking the Right Balance: Determining the Ideal Granularity for IEC 62304 Software Items in Medical Devices
Can We Work on our SaMD After Submitting our 510(k)?
One Way to Speed Up Software 510(k) Submissions
Why Notion is the Best Traceability Tool for Medical Device Startups
Unresolved Anomalies: Best Practices, FAQs, and Examples
Quick Introduction to User Needs and Requirements
How to Grow a 10x Team with Code Reviews
Design Inputs: Best Practices, FAQs, and Examples
Socratic Dialogue about Software Maintenance
How to Grow a 10x Team with Code Reviews
Medical Software Deployment and HIPAA: Cloud, Native, or Hybrid?
A Brief Introduction to the United States Medical Software Regulations, for Developers
Get More Out of Your Annotated Medical Images with Self-Supervised Learning
How to Use Online Chat Effectively
Most Makefiles Should .DELETE_ON_ERROR
2018 FDA Draft Guidance - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Graduate from Sed and Sort to Lnav, the Logfile Navigator
Commentary on Code Complete: Refactoring
Decorating Async JavaScript Functions
Advanced BASH Exercises
Software's Hidden Demon: Poor Code Quality
Database Pools
The Business of Programming Languages
2002 FDA Guidance - General Principles of Software Validation
1997 FDA Guidance - Design Control Guidance for Medical Device Manufacturers