Newsletter | July 29, 2025

07.29.25 -- Cybersecurity Risk Management In Medical Devices: Practical Implementation Of FDA's 2025 Final Guidance

FEATURED EDITORIAL

Implementing FDA's 2025 Cybersecurity Guidance For Medical Devices

By Jayet Moon

The FDA has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025.

INDUSTRY INSIGHTS

Redefining Micro-Molding Excellence Through Capability & Sustainability

Article | Brett Saddoris, Accumold

Explore how Accumold leads in precision micro-molding, offering scalable, sustainable, and vertically integrated solutions for industries demanding high-quality micro components.

Leachables Method Development, Validation And Relevant ICH References

Article | By Will Parker, West Pharmaceutical Services, Inc.

It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

PFAS In Medical Devices: Expert Insights On Frequently Asked Questions

Article | Shalene Thomas, R.E.P, SR., Battelle

Watch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.

Considerations In Selecting A Biomaterial For Implantable Smart Devices

Article | dsm-firmenich

Smart implants revolutionize healthcare with embedded sensors for real-time monitoring. Polycarbonate urethanes offer biocompatibility, overcoming challenges with biomaterials for safer, efficient devices.

RESOURCES

Low-Pressure And High-Pressure Medical Balloons

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

Digital Galvano Scanning System: GM Series

Canon USA, Inc. Optoelectronic Components

ARTICLES YOU MAY HAVE MISSED

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Designing Wearables That Are Truly Patient-Centric

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Brazil's Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical Trials

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Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

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What To Expect When You Move Into Production For The First Time

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Bracing For The Impact Of The Federal Workforce Reduction

BULLETIN BOARD

Development Kit Time Metered Dosing Video

Explore a time-metered dosing system that integrates disc pumps, pneumatic valves, and strobe visualization, offering precise liquid handling for diagnostics, reagent dispensing, inkjet printing, and related applications.

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