Newsletter | November 11, 2025

11.11.25 -- A Better Interpretation Of POH In ISO 24971

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As vascular devices evolve to reach smaller and more complex anatomies, developers face mounting challenges with thinner profiles, tighter seals, and scalable manufacturing. Achieving this balance requires deep materials expertise and integration. Discover how Solesis, powered by Secant Group and Polyzen, unites textile and polymer technologies to help innovators overcome design and manufacturing tradeoffs while delivering advanced, scalable solutions that drive the next generation of vascular devices from concept to clinical success. Learn more here.

FEATURED EDITORIAL

A Better Interpretation Of POH In ISO 24971

Probability of Harm (POH) is essential for accurate risk assessment. Proper scoring requires representing all probabilities transparently, ensuring no risks are overlooked or understated in evaluations.

INDUSTRY INSIGHTS

PHI And Medical Devices: What Device Manufacturers Need To Know

Connected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.

Device History Records – Streamlining Compliance With eDHR

A thorough Device History Record (DHR) is essential for medical device makers, ensuring FDA compliance, documenting production details, and supporting successful market entry.

Mapping RNA And Protein Interactions With Fluorescence Imaging

Histopathology examines tissue to identify disease. Advances in spatial biology and fluorescence imaging enhance diagnostics by mapping RNA and protein interactions within tissues.

Electrophysiology Devices: Streamlining EP And PFA Development

Electrophysiology and pulsed field ablation development require precision and speed. Integrated multi-component suppliers reduce risk and accelerate timelines.

Thin-Wall Cannula Molding: A Study In Precision And Persistence

After five years of development, high-volume micro-injection molding of thin-wall cannulas was perfected, overcoming extrusion limitations and enabling precise, cost-effective medical device production.

RESOURCES

Digital Galvano Scanning System

Biodegradable Polyester Amide Platform For Sustained Delivery Solutions

ARTICLES YOU MAY HAVE MISSED

Considerations For Rapid Prototyping In Medical Device Development

An ROI Model For Community Health Workers In Medtech Trials

Building A Time-Metered Dosing System

How A Strategic Partnership Drove Micro Molding Success

Risk-Based Method Selection For Cleaning Validation Using ASTM Standards

BULLETIN BOARD

Discover Medical Molding Expertise At MEDevice Silicon Valley 2025

Visit Medbio at Booth #941, November 19–20, to explore custom injection molding and assembly solutions, supporting Class I–III devices with quality, compliance, and MedTech innovation.

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