Newsletter | May 12, 2026

05.12.26 -- Advancing Quality And Risk Management In MedTech

SPONSOR

Webinar: 2026 Critical Manufacturing Trends Reshaping Life Sciences in Pharma & Medical Device

Discover how life sciences manufacturers are preparing for 2026 with smarter, more connected operations and scalable innovation. In this MasterControl webinar, explore how unified digital threads, AI-driven manufacturing, and adaptable supply chain strategies are transforming production, quality, and compliance. Learn practical approaches to predictive maintenance, workforce upskilling, and operational resilience in an increasingly automated, data-driven industry. Click here to learn more.

FEATURED EDITORIAL

Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative

This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

INDUSTRY INSIGHTS

What Factors Impact Quality For Medical Device Manufacturers?

This article asks Corporate Vice President of Quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more.

Partnership Goals For Scale-Up Success

As demand for capabilities and resources grows throughout a project, both become strained in-house and the scale-up process becomes a steeper hill to climb.

Key Changes To Biocompatibility And Updates To New FDA Draft Guidance

Review key changes in the upcoming version of ISO 10993-1, regulatory expectations for specific in vitro and in vivo assays, and the FDA's expectations regarding chemical characterization.

Unlocking The Promise Of NAMs

Human-relevant models are reshaping safety and efficacy decisions, but impact depends on selecting the right tools, integrating evidence, and turning complex data into clear, decision‑ready insights.

RESOURCES

Value Added Tubing Capabilities

PolyPeel Peelable Polyester Heat Shrink Tubing

Simplify The Journey With A Combination Product Solution

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