Newsletter | September 2, 2025

09.02.25 -- Regulatory Planning In Early Medtech Development Is The Recipe For Success

FEATURED EDITORIAL

Regulatory Planning In Early Medtech Development Is The Recipe For Success

Historically, many medtech companies have engaged with the FDA in a conservative way, providing only the minimum required to obtain clearance or approval. That mindset is no longer enough. 

INDUSTRY INSIGHTS

Managing Cyber Risk: A Systematic Approach For Legacy Medical Devices

Legacy devices create rising cybersecurity and compliance risks. Manufacturers need risk-informed strategies to balance updates, mitigations, and documentation while protecting safety and trust.

What System And Environmental Factors Impact The Design Of A Solenoid Valve?

Solenoid valve performance depends on fluids, temperature, pressure, environment, and compliance with industry standards.

PFA Tubing For Water Testing, Medical Devices, Semiconductor And Life Sciences

PFA tubing offers high chemical resistance, temperature tolerance, and purity, making it ideal for life sciences, medical, water testing, and semiconductor applications requiring precision and reliability.

The Nuts And Bolts Of Brushless DC Motors

An overview of BLDC motors, their basic components, how they operate, how they differ and where they are used.

5 Things Everyone Should Know About Micro-Molding

Micro-molding isn’t new—it dates back to the “Brick” phone era, though many industries weren’t ready 25 years ago.

ARTICLES YOU MAY HAVE MISSED

The U.K. Now Classifies Ambient Voice Technology As SaMD

The 2025 FDA Enforcement Wake-Up Call

Improving Drug-Device Combination Product Co-Development

Latin America Is Becoming The Testing Ground For AI-Enabled Medical Device Clinical Trials

Minimizing The Impact Of Human Errors Using Relational Risk Analysis

BULLETIN BOARD

Brochure: Engineering Partnership: Solving Your Most Complex Problems

MedBio provides design modifications and enhancements, tooling design, manufacturing automations, quality assurance, assemble, and packaging assistance. Their engineering team consists of plastic, mechanical, electrical, and biomedical engineers.

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