Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide

FEATURED EDITORIAL

By Partha Anbil, MIT Sloan Career Development Office

This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.

Lilly's Unified Mindset For A Global Parenteral And Device Manufacturing Network

A conversation with Syed Abbas Yar-Khan, Eli Lilly and Company, and Jon O'Connell, Bioprocess Online

Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.

INDUSTRY INSIGHTS

Manufacturing Readiness: Why Compliance Is Won Or Lost On The Floor

MasterControl, Inc.

The Clear Solution: Navigating Contamination Control For Ophthalmic Injectables

West Pharmaceutical Services, Inc.

Achieve Leak Free And Safe Connections With Tubing Sleeves

IDEX Health & Science, LLC

From Hype To Health: How Sword Built Evidence That Scales

Castor

Improve Flow Cell Performance While Cutting System Costs

The Lee Company

Look, Ma! How I Solved These Implantable Device Challenges