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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 →

UPS Advantages

Efficiency

Are there efficiencies hidden in your healthcare supply chain?
Healthcare and life sciences companies face increasing cost pressures while striving to increase profits. Regularly re-evaluating supply chains is a part of business, but finding the right logistics provider can lead to meaningful outcomes for business.

Flexibility

Realize a more flexible, agile, and scalable healthcare supply chain
Healthcare companies can be better positioned to seize growth opportunities by working with a logistics provider for instant infrastructure that flexes with their needs, enabling them to be more nimble as the market grows.

Compliance

Get past the red tape and to the patient
By relying on partners with healthcare-specific regulatory expertise to move products through customs, adhere to strict processes, and manage complex paperwork and documentation, companies can realize greater efficiencies, maintain product integrity, and help deliver better patient outcomes.

Featured Articles

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.

April 30, 2026

The Structural Tension at the Heart of MedTech

By Moshe Barel

MedTech leaders must find a balance between the slow, careful world of medicine and the fast-paced expectations of investors. Real success comes from choosing high-quality science over quick shortcuts, as being thorough is the only way to build lasting trust and reach the market.

April 30, 2026
Data protection, intelliectual property, medtech

Cybersecurity Tactics for Medical IoT Devices

By Alexander Podgornyy

Protect patient data with medical IoT security. Learn how AI, Zero Trust, and encryption can prevent cyber threats and secure healthcare IoT devices.

April 30, 2026
Toddler Wearable Health Devices and Monitors

From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market

By Lavanya Ramnath, Srividya Narayanan

Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm performance are critical consideration in dynamic patient populations.

April 28, 2026

Interoperability was Never the Finish Line in Healthcare

By Mika Newton

A long-overdue push to reduce administrative friction, improve access to patient data, and move the system away from workflows that continue to waste time for both patients and providers.

April 20, 2026
navigating regulatory strategy

Beyond Reporting: Realizing Continuous Safety Surveillance for Medical Devices

By Jonathan Messer

Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this capability.

View More Combination Products Articles »

TOPICS

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

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Whether you’re managing complex product portfolios, navigating regulatory pressures, or striving to deliver higher customer satisfaction, this guide will help you understand the tangible benefits of integrating ALM and PLM.

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