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FEATURE ARTICLE

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.  



FEATURED CONTENT

Aligning MedTech Compliance

Navigating U.S.-EU Medical Device Regulation: Innovative Strategies for Global Compliance

By Holger Wagner

The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation (MDR) and the FDA’s Quality Management System Regulation (QMSR) setting new benchmarks.

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.

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.

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.

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.

combination devices

Impact of Combination Products on the Medical Devices Industry

By Partha Anbil

A comprehensive update on the combination products market shows significant industry partnerships, development challenges, and strategic imperatives for success in the sector characterized by dynamic collaboration between pharmaceutical and device companies, rapid product development cycles, and complex regulatory landscapes.

telehealth revenue cycle management

Driving Smarter Workflows in Outpatient Rehab Through Digital Health and Data

By Monte Sandler

Shift Left, an approach to revenue cycle, may help clinics reimagine billing – not as a back-end cleanup job, but as something solved upstream at registration, like eligibility checks and authorizations – before a single claim is ever submitted. Are fewer denials, faster payments, and stronger financial footing possible for clinics already stretched thin?

combination products

Drug-Led vs. Device-Led Combination Products: Determining the Primary Mode of Action (PMOA)

By Celegence

Understanding the nuances is crucial in determining the regulatory submission pathway, data requirements, and even post-approval compliance expectations.






MEDTECH VIEWPOINT

Artificial Intelligence Graphic

AI and Functional Precision Medicine: A Defining Moment for Pediatric Cancer Care

President Trump’s 2025 executive order establishing artificial intelligence (AI) in pediatric cancer as a national priority marks a turning point in medicine. For decades, childhood cancer treatments have advanced slowly, constrained by limited data, small clinical trials, and therapies designed for adults. The convergence of AI and Functional Precision Medicine (FPM) now offers a path to faster, more accurate, and more personalized treatments for children, one that replaces population-based best guesses with evidence-driven precision care.

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.

Epic Venture Partners

Physician Investment in MedTech Startups Can Be a Tricky Topic

By Scott Nelson

The physician has a unique perspective that non-clinical investors don’t: they know firsthand whether a technology will be adopted. They deeply understand if it truly is better for them and their patients.

AI in Healthcare – The EU’s Biggest Opportunity & Challenge

By Karandeep Singh Badwal

A new EU Commission study on the Deployment of AI in Healthcare makes one thing crystal clear: AI isn’t just a buzzword, it could be the lifeline our systems desperately need.

ASK THE EXPERT

medtech development

Product Development Outsourcing Needs Speed, Safety & Certainty

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

medtech design standards

4 FAQs to Notified Bodies

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.

Product Lifecycle Management

Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence

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.

NEWS

  • EndoQuest to Advance Next-Generation Surgical Robotics powered by NVIDIA IGX Thor

  • AtriCure Announces the First Patient Treated in the BoxX-NoAF Clinical Trial

  • Thermo Fisher Scientific to Acquire Clario to Provide Deeper Clinical Insights

  • Hologic to be Acquired by Blackstone and TPG for up to $79 per Share

  • AAMI and TechNation Collaborate to Survey Healthcare Technology Field

  • AMA Launches Center for Digital Health and AI Innovation

  • Merit Medical to Purchase Pentax Medical C2 CryoBalloon Technology

  • Nalu Medical PNS System Acquired by BSCI

  • Seelos Therapeutics, Inc. Assets, Acquired through Bankruptcy

  • Sunrise Labs Rebrands as Suntra MedTech Solutions™

  • Expanded approval for Navitor TAVR system – CE Mark in Europe

  • Philips launches smart telemetry platform for cardiac connectivity beyond the bedside

  • Globe® Pulsed Field System receives FDA approval

  • First Medical Device Approved in Japan for the Treatment of Hypertension

  • Terumo to acquire OrganOx, maker of organ preservation devices, marking strategic entry into organ transplantation market


Upcoming Events & Webinars

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On Demand Events & Webinars

November 12, 2025 – 10:00 am – 11:00 am
From Silos to Synergy: Building the Intelligent MedTech Lifecycle
September 17, 2025 – 12:00 pm – 1:00 pm
Japan Medical Device Reimbursement Strategy
February 26, 2025 – 2:00 pm – 3:00 pm
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025 – 11:00 am – 12:00 pm
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024 – 2:00 pm – 3:00 pm
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024 – 10:00 am – 11:00 am
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery
September 26, 2024 – 1:00 pm – 2:00 pm
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024 – 10:00 am – 11:00 am
Decoding global regulatory pathways: How to classify your Medical Device
July 31, 2024 – 12:00 pm – July 31, 2024 – 1:00 pm
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.
July 18, 2024 – 2:00 pm – 3:00 pm
Now that the EU MDR deadline is passed, how do you sell your device abroad?









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  • Manufacturing Execution
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Upcoming Events & Webinars

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