Newsletter | October 1, 2026

10.01.26 -- New Insights For Medical Device Quality And Design

FEATURED EDITORIAL

You Can't CAPA What You Can't Classify

By Kayla Britt, Britt Biocomputing

An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

 

INDUSTRY INSIGHTS

 

Streamline Medical Device Design With Early Textile Supplier Collaboration

Article | Secant Group & Polyzen, part of the Solesis family of companies

Different considerations often apply to raw material selection, prototyping, and scale-up, and medical device manufacturers can be at a loss for where to start.

 

Extraction And Chemical Characterization Pitfalls In Complex Medical Devices

White Paper | Eurofins

Material-specific extraction strategies can help tissue-derived products, hydrogels, absorbables, and silicone implants avoid regulatory setbacks and costly repeat work.

 

When Clean Is The Key To Precision

Article | Accumold

Cleanroom micro molding ensures ultra-small components meet strict contamination, precision, and performance standards for reliable, compliant devices.

RESOURCES

Ulteeva Purity™: Your Vision. Our Fiber.

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ISO 80369 Compliant Connectors

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