Building a Strong SaMD Culture

Future of Generative AI in Software Medical Devices

Why You Should Join Our Team

510(k) Documentation in 3-Months

FDA’s review timeline for 510(k)s

QVD product code and the associated Special Controls

What is a DICOM Conformance Statement?

SOUP for Engineers

A REAL EXAMPLE OF A PCCP: PRODUCT CODE QVD

WHY YOU SHOULD START YOUR SAMD PROJECT WITH A REGULATORY STRATEGY

Why Should I do a Presub?

Stop saying your device was FDA-approved!

Configuration Management in SaMD

What kind of AI/ML modifications are NOT under the scope of a PCCP?

When should we implement our QMS?

Two VS Code Debugging Tips You Might Not Know

What is an SBOM? Do I need it for my 510k submission?

PCCP vs Note to FIle

Tips for Using Notion

A Short Introduction to Notion

Powerful Debugging Techniques: A Real-World Example

AI/ML From Idea to FDA - Webinar

Phase 1 Regulatory Plan Tutorial

A Brief Presentation on AI/ML + FDA

One Way to Speed Up Software 510(k) Submissions

Our Mission is to Accelerate Progress in the Medical Device Industry

Why Notion is the Best Traceability Tool for Medical Device Startups

User Needs and Requirements

Tips for IEC 62304 Software Decomposition

How to Grow a 10x Team with Code Reviews