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Quality/Regulatory

Featured Articles

November 17, 2025
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.

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.

May 12, 2025
FDA

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

By MedTech Intelligence Staff

The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process.

April 18, 2025

The Agile MedTech Lifecycle: Rethinking Regulatory Adoption in a Time of Global Disruption

By Arjunvasan Ambigapathy

The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does not accommodate evolving regulations, shifting geopolitical realities, or fast-changing healthcare needs.

March 28, 2025
Advancing Medtech

Advancing Medtech in 2025: AI, Field Actions, and Regulatory Intelligence

By Seth Goldenberg, PhD

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR sustainability. As we look ahead to an unpredictable year in medtech, three areas stand out as opportunities for medtech to drive meaningful progress. AI, recall management, and regulatory intelligence could be key differentiators for medtechs — if approached strategically.

March 21, 2025
IVDR

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

By Dr. Oliver Eikenberg

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

March 1, 2025

FDA RECALL UPDATE: Regard Newborn Kit Recall – ROi CPS Neo-Tee T-Piece Resuscitator

Neo-Tee T-Piece resuscitator is being removed due to a undersized spring in the controller.

March 1, 2025

FDA RECAL UPDATE: Power Assist Device – Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+

Speed control circuit board issue that may cause the motor to be unresponsive to the user.

View More Quality/Regulatory Articles »

News & Views

  • What is a Service+Tech Model?

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

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

  • Globe® Pulsed Field System receives FDA approval

  • Boston Scientific Vascular Stent Recall: Carotid WALLSTENT Monorail Endoprosthesis

  • IQVIA, Veeva Announce Long-term Clinical and Commercial Partnerships; Resolve of All Disputes

  • Labcorp Launches First FDA-Cleared Blood Test for Alzheimer’s Disease 

  • Why Your Regulatory Compliance Strategies Aren’t Keeping Pace

  • Top MedTech Trends in 2025

  • Streamlining Compliance for Quicker MedTech Market Entry

Upcoming Events & Webinars

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On Demand Events & Webinars

December 1, 2025
From Silos to Synergy: Building the Intelligent MedTech Lifecycle
September 17, 2025
Japan Medical Device Reimbursement Strategy
February 26, 2025
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery






Quality/Regulatory Archive

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