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Quality/Regulatory

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

Drama Continues with Duodenoscopes

The agency has entered the next phase of requests: Postmarket surveillance studies.

Continue reading →

October 13, 2015

CDRH’s Shuren: Future is Bright, We Need to Take Risks

By Maria Fontanazza

As the agency continues to try to do more with fewer resources, taking additional risks is imperative to move forward.

Continue reading →

Munroe and Cohen, Reimbursement Report
October 12, 2015
Munroe and Cohen, Reimbursement Report
Reimbursement Report

When Can I Appeal My Health Insurance Carrier’s Decision?

By Kristofer C. Munroe, Aaron Cohen

That depends on where you sit.

Continue reading →

Nicole Littman, Quorum Consulting
October 8, 2015
Nicole Littman, Quorum Consulting
Soapbox

CMS Reveals Rationale for NTAP Decisions in Rule Making

By Nicole Littmann

What can we learn about how new technologies become eligible for additional payment?

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Dr. Christopher Joseph Devine, President, Devine Guidance International
October 7, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Gasoline in the Stockroom, Burning Down the House!

By Dr. Christopher Joseph Devine

Storing gasoline next to orthopedic trays and instrument trays just isn’t a good idea.

Continue reading →

October 7, 2015
Ameing for Asia

Key Regulatory Issues for Establishing New Green Field Device Factory in China

By Ames Gross

Remember, several basic regulatory approvals are required.

Continue reading →

Joely Gardner, President and CEO, Human Factors Research
October 5, 2015
Joely Gardner, President and CEO, Human Factors Research

Will Your IFU Meet Usability Requirements?

By Joely Gardner

Well-written and usable instructions are critical for all users.

Continue reading →

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

If It Walks Like a Duck and Quacks Like a Duck It’s Probably a Duck

By Dr. Christopher Joseph Devine

Device establishments should be able to read and comprehend 21 CFR Part 807.

Continue reading →

Jon Speer, Greenlight.guru
September 28, 2015
Jon Speer, Greenlight.guru
Soapbox

4 Reasons Your Risk Management Approach is Wrong

By Jon Speer

Risk Management is the single most important topic impacting the medical device industry today.

Continue reading →

Carl Fischer, FDA, CDRH, Complaints, MedTech Intelligence
September 25, 2015
Carl Fischer, FDA, CDRH, Complaints, MedTech Intelligence

What Are Complaints and How Does FDA Handle Them?

By MedTech Intelligence Staff

CDRH’s Carl Fischer shares the agency’s approach to organizing and managing complaints.

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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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