J. David Giese

Articles by J. David Giese

• The Ultimate 510(k) Checklist
• FDA Cybersecurity Readiness Survey
• FDA Pre-Subs: Best Practices, FAQs, and Examples
• PCCPs: Best Practices, FAQs, and Examples
• Medical Device SBOMs: Best Practices, FAQs, and Examples
• Medical Device Cybersecurity: Best Practices, FAQs, and Examples
• Off-The-Shelf Software: Best Practices, FAQs, and Examples
• Can a Glossary Speed Up Your FDA Review?
• Can Your Software Diagrams Slow Down Your FDA Submission?
• Draft FDA Generative AI Guidance
• How to Avoid $100k AI/ML Mistake
• To Rewrite or Not: From Prototype to FDA-Compliant Software
• Digital Therapeutics: Best Practices, FAQs, and Examples
• Medical-Device Software Regulations: 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
• “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)?
• 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• 2018 FDA Draft Guidance - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices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