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Ultimate Posts

IVDR

IVD Intended Purpose: Why it matters more than ever under IVDR

March 21, 2025 6:59 am | By Rich West

Clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With IVDR compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies? Read more →

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Featured Articles

May 11, 2026
Field Service Technology

The Hidden Design Flaw in Medical Device Service Technology

By Ryan Condon

Health systems globally face higher utilization, tighter scrutiny, and less operational slack. As devices become more connected and service events more consequential, the limitations of generic service technology become harder to ignore.

May 11, 2026
Cerevasc

An Endovascular Approach to Neurological Diseases Can Shift the Treatment Paradigm

By Dan Levangie

Ensuring that proven therapies can be delivered safely and accessibly to the patients who need them provides opportunity in what we innovate and in how broadly those innovations can reach.

May 11, 2026

Why Gen AI is a Win for MedTech: And, How to Unlock its Potential with the Right Policies

By Jonathan Burk

Without formal policies and governance, MedTech organizations face risks to intellectual property, product quality, and ultimately patient safety. Thoughtful AI governance enables development teams to capture efficiency gains while maintaining the rigor that the industry demands.

May 11, 2026
Data protection, intelliectual property, medtech

The Medical Device Cybersecurity Gap Hiding in Plain Sight

By Partha Anbil, Saravanan Manikandan

In healthcare, a cyber vulnerability is not just an IT problem. It can quickly become a patient-care problem.

May 10, 2026
Trust in AI

Maintaining trust in medical AI: Monitoring and managing model lifecycle

By Anna Vuolo

Healthcare environments are dynamic with patient populations, clinical practices and data collection methods continuously evolving. Similarly, effective AI systems depend on more than performance at initial deployment. They must be monitored and managed throughout their lifecycle to remain reliable, clinically relevant, and safe.

April 30, 2026

From Prototype to Production: Building a Validation Strategy That Scales with Manufacturing Volume

By Aniruddha Dhole

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?

April 30, 2026

Managing AI in Medical Technology: From Innovation to Compliance

By Ali Behbahani, Dr. Ibrahim Halfaoui

Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and lifecycle governance. An AI management system (AIMS) aligned with ISO/IEC 42001 provides a structured way to address these challenges while significantly improving efficiency, quality, and innovation outcomes — and ensuring AI system are  effective, safe, compliant, and trustworthy.

April 30, 2026
Artificial intelligence, medical devices

Seven Things Every Medical Device Manufacturer Must Know Before Integrating AI

By Jonathan Ripley, Ruaidhrí Primrose

No longer a horizon technology, Artificial Intelligence in healthcare has reached a level of real-world performance that makes clinical value demonstrable at a critical time in healthcare – a time of clinician shortages, backlogs, and rising costs that have made access to treatment a challenge.

View More Combination Products Articles »

TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

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