Quality/Regulatory Page | MedTech Intelligence

Featured Articles

April 19, 2018

HSCA Releases Extensive Cybersecurity Considerations

By MedTech Intelligence Staff

The Healthcare Supply Chain Association releases a laundry list of areas in which device companies and providers must increase security of devices and networks.

April 9, 2018

FDA Restricts Sale of Bayer’s Essure

By MedTech Intelligence Staff

The agency wants to make sure that all patients receive information about the risks of the female contraception device prior to implantation.

April 3, 2018

Cybersecurity: How Vulnerable Are You?

By MedTech Intelligence Staff

Next month cybersecurity experts from FDA, medical device companies and other healthcare organizations with gather to talk strategy and best practices for designing and evaluating secure technologies.

March 30, 2018

FDA Allows Marketing of First Interoperable Continuous Glucose Monitoring System

By MedTech Intelligence Staff

About the size of a quarter, the patch transmits real-time glucose readings every five minutes.

March 26, 2018

BD Recalls Vacutainer Blood Collection Tubes Due to Chemical Interference

By MedTech Intelligence Staff

The issue causes interference in the accuracy of the test method.

March 19, 2018

Japan a Major Player, But Be Prepared

By Maria Fontanazza

Although an expensive and challenging regulatory market, Japan’s aging population offers plenty of opportunities for device companies.

March 12, 2018

Olympus, Fujifilm and Pentax Warned by FDA for Compliance Failures

By MedTech Intelligence Staff

The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.

March 6, 2018

Abbott Wins FDA Approval for World’s Smallest Mechanical Heart Valve

By MedTech Intelligence Staff

The 15-mm valve size is small enough to use in newborn patients to treat heart defects.

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Columns

April 4, 2018

Devine Guidance

Risk-Based Purchasing Controls

By Dr. Christopher Joseph Devine

Managing suppliers is critical, and your processes in doing so must be documented.

March 31, 2018

Devine Guidance

When Furry Critters Aren’t So Cute

By Dr. Christopher Joseph Devine

APRIL FOOL'S! FDA inspectors don’t want to discover hungry rodents enjoying a meal of device history records.

March 20, 2018

Soapbox

Why Is Quality Focusing on Compliance?

By Daniel R. Matlis

Excessive focus on compliance can create hurdles in cultivating quality and innovation.

March 14, 2018

Soapbox

IVDR signals In Vitro Industry Shake-up

By Brian Moan, Norman Rabin

Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.

March 13, 2018

Devine Guidance

Duodenoscopes Take Two

By Dr. Christopher Joseph Devine

Failure to comply with FDA’s wishes landed three companies warning letters.

Upcoming Events & Webinars

May 1, 2018 – May 2, 2018

Medical Cybersecurity: Vulnerability and Patch Management

This conference brings together leading experts from FDA, the medical device industry, hospitals, and independent consultants to share experiences and discuss strategies and best practices for designing and evaluating secure technologies and ensuring system and patient safety.

May 14, 2018 – May 15, 2018

Medical Device Recalls: Current Topics and New Initiatives

Join the sixth annual MedTech Intelligence Medical Device Recalls conference for presentations, panel discussions, and networking with senior FDA and industry experts to learn about recent and upcoming changes and their practical impact on how companies manage the decision-making and execution of recalls.