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Quality/Regulatory

Featured Articles

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.

March 1, 2025

FDA RECALL UPDATE:
Biosense Webster Varipulse Use Instructions

Use instructions updated for Varipulse ablation catheter due to a high rate of stroke or transient ischemic attack.

February 25, 2025

FDA’s Revolving Door? The Agency moves to rehire CDRH staffers fired days earlier

By MedTech Intelligence Staff

The FDA hasn’t released official numbers on the terminations, but former FDA officials have pegged the number at roughly 700, with more than 220 coming from the medical device center. That would represent roughly 10% of the program’s total staffing.

View More Quality/Regulatory Articles »

News & Views

  • FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

  • FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

  • Increased productivity through AI?

  • Regulation vs. Deregulation: Finding the Right Balance for AI-Driven Healthcare

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

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

  • FDA RECALL UPDATE: Biosense Webster Varipulse Use Instructions

  • FDA’s Revolving Door? The Agency moves to rehire CDRH staffers fired days earlier

  • Elizabeth Holmes’s Appeal to Overturn Conviction Is Denied

  • Sweeping FDA Cuts Hit CDRH Staffer’s Inboxes

Upcoming Events & Webinars

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On Demand Events & Webinars

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






Quality/Regulatory Archive
  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
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  • Quality/Regulatory

Upcoming Events & Webinars

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On Demand Events & Webinars

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

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