Back to all thoughts

Thoughts on

Regulatory Analysis

Product Management & FDA's AI Good Machine Learning Practices

January 25, 2024
AI
Regulatory Analysis
Software

A mindmap for AI validation and actionable steps Product Managers can take when incorporating AI/ML into digital health, biopharma, or medical device products in order to speed the product to market.

Navigating the Regulatory Horizon: Predicting FDA Guidance for 2024 and Staying Nimble

January 24, 2024
Data Governance
AI
Regulatory Analysis

As we step into 2024, medical device manufacturers are poised for a year of regulatory evolution, guided by the FDA's upcoming guidance documents.

Striking the Balance: Safeguarding Clinical Trials with AI

January 24, 2024
Data Governance
AI
Regulatory Analysis

This is the first post in a series on using AI/ML in drug development, considerations for benefit-risk analysis, and potential mitigations to support responsible AI.