Newsletter | January 7, 2025

01.07.25 -- How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies?

FEATURED EDITORIAL

How Does FDA Harmonization With ISO 13485 Impact U.S.-Focused Companies?

By Mayur Patel, Hilde Viroux, and Emanuel Wasson

FDA’s harmonization of the Quality System Regulation with ISO 13485 was long expected. Aligning 21 CFR 820 with ISO 13485 gives companies one global standard for quality management system compliance.

INDUSTRY INSIGHTS

Resonant Wireless Power Transfer In Implantable Medical Devices

Article | Knowles Precision Devices DLI

Battery life and replacements can be problematic for implantable medical devices. Resonant wireless power transfer (RWPT) provides a safe and efficient solution.

Solenoid Valve Mechanisms: Understanding Force Balance Equations

Article | The Lee Company

Discover how to ensure optimal performance of solenoid valves by understanding and calculating the forces acting on it.

A Proven Versatile, Easy, And Environmentally Sustainable Solution

Application Note | By Kevin Norfleet and Rob Haley, Celanese

From feasibility to development to commercialization, our scientists and engineers are there to provide development services, GMP material supply, and regulatory support.

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Decoding The FDA's Final Guidance On PCCPs For AI-Enabled Device Software Functions

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A Closer Look At FDA's Controversial Rule On Laboratory Developed Tests

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How The EU AI Act Impacts Medical Device Manufacturers

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Medtech: Capitalize On These 4 Trends To Thrive In 2025

RESOURCES

Pharma+ Tubing Retainers

Nordson MEDICAL

Micro Stepping Motor

Canon USA, Inc. Optoelectronic Components

The Intersection Of Material Science And Medical Device Design

Battelle

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