Newsletter | September 8, 2026

09.08.26 -- Are Your SaMD Design Controls Ready For What's Next?

FEATURED EDITORIAL

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

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.

INDUSTRY INSIGHTS

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

White Paper | MasterControl, Inc.

Achieve continuous regulatory readiness by embedding ALCOA++ compliance directly into manufacturing workflows to eliminate paper-based documentation risks.

The Clear Solution: Navigating Contamination Control For Ophthalmic Injectables

Article | West Pharmaceutical Services, Inc.

As the intravitreal therapy market grows and applicable regulations evolve, continued compliance demands technological savvy and rigorous contamination control.

Achieve Leak Free And Safe Connections With Tubing Sleeves

Article | IDEX Health & Science, LLC

Tubing sleeves simplify capillary connections, reducing leaks, dead volume, and complexity while providing reliable, high-pressure, and temperature-resistant solutions for life science applications.

From Hype To Health: How Sword Built Evidence That Scales

Webinar | Castor

A candid look at balancing resource constraints with rigorous clinical strategy to earn trust, reimbursement, and real growth.

RESOURCES

Pharma Services Fill, Finish & Drug Delivery CDMO

SMC Ltd.

Medical Grade Capacitors: MD Series

Knowles Precision Devices DLI

Helping Innovations Become Reality

Medbio

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