Skip to main content
  • Home
  • About Us
  • Advisory Board
  • Advertise
  • Editorial Submissions
  • Contact Us

  • Get The Newsletter!
  • View The Latest Newsletter
  • Follow me on Twitter
  • Friend me on Facebook
  • Connect with me on LinkedIn
  • Subscribe to me on YouTube
  • Subscribe to my RSS Feed

Menu

Skip to content
  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory
  • Resource Centers
    • Post-Market Surveillance Resource Center
    • MedTech Regulatory Management (RIM) Resource Center
    • EU MDR and IVDR Resource Center
    • Medical Device Design & Manufacturing Resource Center
  • Events & Webinars
  • Library

Quality/Regulatory

FDA
December 8, 2015
FDA

FDA Announces Cybersecurity Public Workshop

By MedTech Intelligence Staff

The agency will bring together major stakeholders to discuss challenges in medical device cybersecurity.

Continue reading →

December 7, 2015

New Frontiers for Medical Tourism in Asia

By Ames Gross

The booming industry is creating new opportunities for medtech manufacturers.

Continue reading →

Dr. Christopher Joseph Devine, President, Devine Guidance International
December 1, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Fail to Respond to Form 483 Observations and Win a Warning Letter

By Dr. Christopher Joseph Devine

A monumental screw up, complete with bad quality, regulatory and statutory practices.

Continue reading →

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

Bad Clinicians

By Dr. Christopher Joseph Devine

Few things motivate FDA faster than a significant number of adverse events, especially deaths.

Continue reading →

Technology hazards in hospirals, ECRI
November 22, 2015
Technology hazards in hospirals, ECRI

Solving Technology Hazards in Hospitals

By Maria Fontanazza

ECRI’s top 10 hazards list drew attention to technology issues, and device manufacturers should be communicating with hospitals to address the problems.

Continue reading →

Nicholas Daniell, Sunrise Labs
November 19, 2015
Nicholas Daniell, Sunrise Labs
Soapbox

Robust Security Planning Requires Change in Mindset

By Nicholas Daniell

Product architects are challenged to address security throughout the device lifecycle.

Continue reading →

Dr. Christopher Joseph Devine, President, Devine Guidance International
November 18, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The Haunting Consent Decree

By Dr. Christopher Joseph Devine

FDA recently ordered a manufacturer of automated endoscope reprocessors to recall product following a consent decree from 2007.

Continue reading →

November 17, 2015

Vague FDA Guidance Not Helping Cybersecurity Challenges

By Maria Fontanazza

Cybersecurity considerations must be part of the design and implementation process.

Continue reading →

Jon Speer, Greenlight.guru
November 12, 2015
Jon Speer, Greenlight.guru
Soapbox

7 Steps to Respond to FDA 483 Inspection Observations

By Jon Speer

Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency.

Continue reading →

Dr. Christopher Joseph Devine, President, Devine Guidance International
November 11, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

FDA a Pain in the Butt for Hemorrhoid Management System Establishment

By Dr. Christopher Joseph Devine

Failure to provide records during an inspection will undoubtedly lead to a warning letter.

Continue reading →

Post navigation

  • Previous
  • 1
  • …
  • 92
  • 93
  • 94
  • 95
  • 96
  • …
  • 112
  • Next

Upcoming Events & Webinars

No posts found.



On Demand Events & Webinars

No posts found.






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.

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

Upcoming Events & Webinars

No posts found.



On Demand Events & Webinars

No posts found.


Combination Products

Contact Us

  • Advertising Opportunities
  • Editorial Submissions
  • General Inquiries
  • Privacy Policy
  • Cookie Policy
  • Sign Up for Newsletters

Innovative Publishing Company, Inc.

  • FoodSafetyTech
  • Food Safety Consortium Conference & Expo
  • MedTech Intelligence
  • Cannabis Industry Journal

© Copyright 2015 - 2025 Innovative Publishing Co., Inc., All Rights Reserved

Other Innovative Publishing Co., Inc. Sites: Food Safety Tech  |  Cannabis Industry Journal

We are using cookies to give you the best experience on our website.

You can find out more about which cookies we are using or switch them off in .

MedTech Intelligence
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Strictly Necessary Cookies

Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

We use tracking pixels that set your arrival time at our website, this is used as part of our anti-spam and security measures. Disabling this tracking pixel would disable some of our security measures, and is therefore considered necessary for the safe operation of the website. This tracking pixel is cleared from your system when you delete files in your history.

We also use cookies to store your preferences regarding the setting of 3rd Party Cookies.

If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.

Cookie Policy

A browser cookie is a small piece of data that is stored on your device to help websites and mobile apps remember things about you. Other technologies, including Web storage and identifiers associated with your device, may be used for similar purposes. In this policy, we say “cookies” to discuss all of these technologies.

Our Privacy Policy explains how we collect and use information from and about you when you use This website and certain other Innovative Publishing Co LLC services. This policy explains more about how we use cookies and your related choices.

How We Use Cookies

Data generated from cookies and other behavioral tracking technology is not made available to any outside parties, and is only used in the aggregate to make editorial decisions for the websites. Most browsers are initially set up to accept cookies, but you can reset your browser to refuse all cookies or to indicate when a cookie is being sent by visiting this Cookies Policy page. If your cookies are disabled in the browser, neither the tracking cookie nor the preference cookie is set, and you are in effect opted-out.

In other cases, our advertisers request to use third-party tracking to verify our ad delivery, or to remarket their products and/or services to you on other websites. You may opt-out of these tracking pixels by adjusting the Do Not Track settings in your browser, or by visiting the Network Advertising Initiative Opt Out page.

You have control over whether, how, and when cookies and other tracking technologies are installed on your devices. Although each browser is different, most browsers enable their users to access and edit their cookie preferences in their browser settings. The rejection or disabling of some cookies may impact certain features of the site or to cause some of the website’s services not to function properly.

Individuals may opt-out of 3rd Party Cookies used on IPC websites by adjusting your cookie preferences through this Cookie Preferences tool, or by setting web browser settings to refuse cookies and similar tracking mechanisms. Please note that web browsers operate using different identifiers. As such, you must adjust your settings in each web browser and for each computer or device on which you would like to opt-out on. Further, if you simply delete your cookies, you will need to remove cookies from your device after every visit to the websites. You may download a browser plugin that will help you maintain your opt-out choices by visiting www.aboutads.info/pmc. You may block cookies entirely by disabling cookie use in your browser or by setting your browser to ask for your permission before setting a cookie. Blocking cookies entirely may cause some websites to work incorrectly or less effectively.

The use of online tracking mechanisms by third parties is subject to those third parties’ own privacy policies, and not this Policy. If you prefer to prevent third parties from setting and accessing cookies on your computer, you may set your browser to block all cookies. Additionally, you may remove yourself from the targeted advertising of companies within the Network Advertising Initiative by opting out here, or of companies participating in the Digital Advertising Alliance program by opting out here.