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Quality/Regulatory

Checkbox
January 4, 2016
Checkbox

Design Verification: Process Considerations Before Testing

By Roberta Goode

Prior to design verification of packaged products, consider the following process-related elements.

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Design verification in medical devices
January 4, 2016
Design verification in medical devices

Design Verification: Ensure Product Protection throughout the Supply Chain

By Roberta Goode

This three-part series explains how an all-encompassing testing approach will improve product reliability and secure your bottom line.

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FDA
December 29, 2015
FDA

CDRH Wants to Publish at Least 12 Final Guidance Documents in 2016

By MedTech Intelligence Staff

From human factors to laboratory developed tests to medical device reporting, CDRH has ambitious plans for 2016.

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Alert
December 28, 2015
Alert

Most Serious Medical Device Recalls of 2015

By Maria Fontanazza

Almost half as many devices were recalled this year compared to 2014.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
December 28, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Detention Never a Good Thing, Even for Medical Devices

By Dr. Christopher Joseph Devine

If you climb into FDA’s sandbox, be prepared to play by the rules.

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Evolution of Medtronic pacemakers, Maastricht
December 21, 2015
Evolution of Medtronic pacemakers, Maastricht

Most Popular Stories of 2015

A review of the articles you found most interesting this year.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
December 21, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The Twelve Days of Christmas: Not Exactly!

By Dr. Christopher Joseph Devine

A twist on the classic holiday song, complete with FDA condemnation.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
December 16, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Electrify the Fence Surrounding the Quarantine Cage?

By Dr. Christopher Joseph Devine

FDA takes control of non-conforming product seriously.

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December 15, 2015
Ameing for Asia

Are Clinical Trials Needed to Register Your Device in China?

In lieu of trials, some companies may be able to submit a CER.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
December 9, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Dr. D is Mean Spirited, Seriously?

By Dr. Christopher Joseph Devine

Regardless, let’s look at stupidity in its highest form.

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Columns

May 12, 2025

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

By MedTech Intelligence Staff
FDA

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 in 2025:
AI, Field Actions, and Regulatory Intelligence

By Seth Goldenberg, PhD
Advancing Medtech

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

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

By Dr. Oliver Eikenberg
IVDR

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 21, 2025

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

By Dr. Oliver Eikenberg
IVDR

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?

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.

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