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Upcoming Events & Webinars

November 12, 2025 – 10:00 am – 11:00 am
From Silos to Synergy: Building the Intelligent MedTech Lifecycle

Join us to explore how a connected, intelligent approach to the product lifecycle—powered by AI—can unlock new levels of operational excellence, spark innovation, and drive long-term value in MedTech.

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 →

Upcoming Events & Webinars

November 12, 2025 – 10:00 am – 11:00 am
From Silos to Synergy: Building the Intelligent MedTech Lifecycle




Featured Articles

November 9, 2025
AI Compliance in Medical Devices

What is a Service+Tech Model?

By Lakshmeenarayana Goundalkar (LGG)

The Service+Tech model embeds AI into the workflow of regulatory experts rather than treating technology as a standalone tool; an approach allowing organizations to adopt AI immediately, with no risk and no R&D investment, while keeping full confidence in the accuracy and regulatory readiness of submissions.

October 30, 2025

The Overlooked Role of Family Caregivers in Home-Based Care: Addressing Challenges and Leveraging Technology

By Jiang Li

Examines the increasing strain on caregivers in home-based care models, the level of support they need for various stages of care, and how improved technological devices and infrastructure can help alleviate their burden.

October 28, 2025
Battery-Powered Medtech

Beyond Batteries: The Urgent Case for RF-Powered Medical Devices in Modern Healthcare

By Dr. Charles Greene

Hospitals are adding more connected devices than ever before—from patient wearables to asset tracking systems. Yet this digital transformation is being bottlenecked by an antiquated power infrastructure dependent on single-use batteries that create waste, demand constant maintenance, and compromise device reliability.

October 15, 2025
Disruptive Innovation in MedTech

Disruptive Innovation in MedTech: Evolving Characteristics and Modern Realities

By Partha Anbil

Converting promising technologies into durable outcomes, experience, and cost at scale with evolving technologies and disruptive innovation.

October 13, 2025
medtech development

Product Development Outsourcing Needs Speed, Safety & Certainty

By MTI Marketing Staff

Seek partners who can see your vision — the full picture, anticipate challenges, and help you navigate complexity with confidence.

September 30, 2025
medtech design standards

4 FAQs to Notified Bodies

By Kevin Holochwost

Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.

September 26, 2025
Product Lifecycle Management

Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence

By MedTech Intelligence Staff, Rene Zoelfl

To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.

September 11, 2025
Clinical Evaluation Reports and Artificial Intelligence

Beyond Automation: How AI Transforms Clinical Evaluation Reports into Strategic Regulatory Assets

By Celegence

Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, surveillance, and quality management to enable real-time adaptability. Artificial Intelligence (AI) , in particular, is playing an increasingly critical role in helping manufacturers meet expanding regulatory expectations.

View More Combination Products Articles »

TOPICS

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

Upcoming Events & Webinars

November 12, 2025 – 10:00 am – 11:00 am
From Silos to Synergy: Building the Intelligent MedTech Lifecycle

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