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Tue

Aug, 25 2026

From Concept to Commercialization: Developing a Drug-Device Combination Product

Developing a drug-device combination product is not simply a matter of placing a medicinal product...

Mon

Aug, 24 2026

Medical Device Development vs. Combination Product Development

Medical devices are developed to diagnose, prevent, monitor, or treat medical conditions, with safety, performance,...

Mon

Jul, 27 2026

FDA Medical Device Submissions: Strategic Insights for Success

The regulatory landscape for medical devices is shifting rapidly. Over the last 18 months, significant...

Sat

Jul, 25 2026

Guide to the FDA’s QMSR Transition – Feb, 2026

For nearly three decades, medical device manufacturers operating in the United States have looked to the Quality System Regulation...

Thu

Jul, 23 2026

EU Commission Drafts Guidelines on Classifying High-Risk AI Systems 

Introduction: A New Layer of Compliance  Artificial Intelligence (AI) is reshaping industries across Europe, but...

Tue

Jun, 23 2026

Korea’s 2025 Medical Product Market – Digital Shift and Local Innovation

South Korea’s medical products market is undergoing a massive transformation, driven by two clear forces:...

Wed

Jun, 17 2026

Portugal’s New “No-Reuse” List – The Regulatory Reality of Medical Device Reprocessing 

For years, healthcare providers across Europe have walked a tightrope when managing the life cycle of medical...

Fri

May, 29 2026

5 Advanced Materials Powering Orthopedic Progress 

Orthopedics is improving thanks to new materials that interact better with the human body. These materials are often stronger, more durable, and designed to better...

Wed

May, 27 2026

When Medical Devices Go Wrong – 10 High-Risk Products Exposed 

Medical devices play a vital role in diagnosing, treating, and improving patients’ lives. Most undergo extensive testing and perform safely,...

Tue

May, 26 2026

Smarter Healthcare Starts with Connected Medical Devices 

As healthcare continues to evolve, connected medical devices (CMD) have become an essential part of modern patient care. These...

Thu

Apr, 23 2026

Founder’s Guide to First-Time ISO Certification

The pillars of any successful business are excellence, protection, and durability. ISO certification ties them...

Sat

Apr, 18 2026

ISO 14155:2026 – What the New Edition Means for Medical Device Clinical Investigations 

Staying up to date in the medical device industry can be challenging, with regulatory expectations...

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