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Quality/Regulatory

July 20, 2015

How New FDA Expectations for Human Factors Affect Process and Medical Device Submissions

By James Jackson

FDA’s perspective on human factors and usability engineering has evolved.

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July 19, 2015

UL Discusses Cybersecurity Considerations for Medical Devices

Learn about the current guidance for Cybersecurity in the medical industry and strategies for how you can demonstrate to regulators, purchasers, and users that you’ve addressed these threats.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
July 14, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

No Excuses for Repeat Violations!

By Dr. Christopher Joseph Devine

Get an instant warning letter with repeat Form 483 observations.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
June 30, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Heigh-Ho, Heigh-Ho, It’s Off to Jail You Go

By Dr. Christopher Joseph Devine

Charlie Chi, former CEO of OtisMed Corp, is sentenced to prison for shipping adulterated medical devices into interstate commerce.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
June 23, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Establishments Must Calibrate and Maintain their Equipment, Who Knew?

By Dr. Christopher Joseph Devine

Production and operations managers—make sure your preventative maintenance procedures are up to snuff.

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June 22, 2015

Silos and Software in Medical Devices

By Maria Fontanazza

With the increased complexity of devices, a streamlined approach to managing product development risks and documenting compliance is challenging but perhaps more important than ever.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
June 17, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Truth in Advertising, FDA Cares

By Dr. Christopher Joseph Devine

Some companies just don’t get it. If a device has been cleared or approved for a specific indication, it can only be advertised for that specific indication.

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June 17, 2015
Ameing for Asia

The Copycat Culture in China’s Medical Device Industry

By Ames Gross

There are several steps you can take to protect your IP and avoid medical device piracy in China.

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June 17, 2015

Meshing Drug and Device Manufacturers in Risk Management

By Maria Fontanazza

Differing approaches to risk could hamper further growth of combination products.

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June 11, 2015

Combination Products Progressing in Fits and Starts

By Maria Fontanazza

The creation of the Office of Combination Products more than a decade ago may have been a big step forward, but frustrations surrounding policy-making and coordination between CDRH, CDER and CBER remain.

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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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