Newsletter | November 12, 2026

11.12.26 -- The Standard You Stopped Reading In 1996 Just Rewrote Your 2030 Audit

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Medbio – Scalable Precision Molding Solutions

Medbio is a trusted healthcare contract manufacturer, offering precision cleanroom custom molding, end-to-end manufacturing, and value-added assembly. Medbio’s full range of solutions—everything from molded components to complete assemblies—is built to serve customers at every stage, scaling from start-ups and new product development to full-volume commercialization. Bring us your next challenge and let Medbio help bring your products to market faster and cost effectively.

FEATURED EDITORIAL

The Standard You Stopped Reading In 1996 Just Rewrote Your 2030 Audit

On Sept. 16, 2026, ISO published the sixth edition of ISO 9001. Most medical device professionals shrugged, feeling that we live in ISO 13485. That shrug is a mistake.

INDUSTRY INSIGHTS

Navigating Recent Changes To USP <788>

A recent USP <788> revision introduces meaningful changes to particulate matter testing methods, with implications for laboratories working with small-volume injectable products.

Accuracy, Safety And Ease Of Use

Safety, ease of use, and accuracy guide modern medical device design, advancing through improved materials, engineering innovation, standards adoption, and user‑centered development.

Why OEMs Choose IDEX For Fluidics And Optics Systems

Explore how OEMs optimize instrument performance with precision fluidics, optical technologies, and integrated subsystems that improve reliability and accelerate development.

Key Considerations For Selecting A Medical Pump

When selecting a pump for medical devices, pressure and flow rate alone may not be sufficient. A thorough review of selection criteria is crucial to ensure the correct pump is chosen.

The Importance Of Material Selection In Micro Molding Applications

Learn how the critical properties of micro molded components - such as strength, flexibility, and thermal resistance - are shaped by the intricacies of material selection.

RESOURCES

The Business Case For Electronic GxP Management

EU MDR And ISO 14155-Compliant Device Data Without A Team

BULLETIN BOARD

Medbio: Right-Sized For Medical Manufacturing

Medical OEMs need a manufacturing partner that delivers technical expertise, responsiveness, quality, accountability, and scalability from development through production.

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