Skip to main content
  • Home
  • About Us
  • Advisory Board
  • Advertise
  • Editorial Submissions
  • Contact Us
  • Subscribe to 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
  • MedTech Economics
  • Policy
  • Manufacturing Execution
  • Product Design & Development
  • Quality & Compliance
  • Digital Health
  • Resource Library
  • Events & Webinars


Footsteps
February 13, 2017
Footsteps

Remediation: Risk Priorities

By Maria Fontanazza

Part III of the series on remediation looks at how companies can tie risk priorities into the remediation process.

Continue reading →

Footsteps
February 7, 2017
Footsteps

Remediation: Considerations During the Process

By Maria Fontanazza

Is your risk management process fully operational right now?

Continue reading →

January 30, 2017

Build an Effective Global Regulatory Strategy

By Laura Elan, Linda M. Chatwin, Esq, RAC

Getting through the complex maze of regulatory requirements can be an overwhelming process for any medical device company.

Continue reading →

Footsteps
January 24, 2017
Footsteps

Remediation: What Challenges Do Device Companies Face?

By Maria Fontanazza

A three-part series on quality system remediation and what manufacturers need to do to get through the process.

Continue reading →

CE Mark
January 18, 2017
CE Mark

Thinking of Transferring Your Notified Body? You’re Probably Not Alone

By Mark Leimbeck

Fewer resources and more requirements are hindering the process.

Continue reading →

Jacob Andra, U.S. Translation Company
January 9, 2017
Jacob Andra, U.S. Translation Company

Medical Innovation in an Age of Overregulation

By Jacob Andra

Do regulators have a disincentive to approve medical devices?

Continue reading →

Cybersecurity
December 28, 2016
Cybersecurity

FDA Releases Final Guidance on Postmarket Cybersecurity

By MedTech Intelligence Staff

Device manufacturers need to identify, monitor and address cybersecurity vulnerabilities as part of postmarket device management.

Continue reading →

December 12, 2016

21st Century Cures Act Passes Senate, Several Impacts to Device Industry

By MedTech Intelligence Staff

Several provisions are aimed at accelerating device innovation and access to medical products.

Continue reading →

FDA
December 5, 2016
FDA

Providing More Guidance and Agency Experts Among FDA Combination Products Priorities

By MedTech Intelligence Staff

FDA releases achievements of its Combination Product Review Program, along with next steps for the near term.

Continue reading →

Human factors, use error
November 10, 2016
Human factors, use error

Medical Device Use Error: Focus on the Severity of Harm

By Allison Strochlic, Michael Wiklund

Severity of harm is what ultimately matters most in terms of protecting patients from the consequences of use errors.

Continue reading →

Post navigation

  • Previous
  • 1
  • …
  • 12
  • 13
  • 14
  • 15
  • 16
  • …
  • 22
  • Next

Upcoming Events & Webinars

No posts found.



On Demand Events & Webinars

No posts found.






Columns

May 14, 2024

FDA Issues Final Guidance on Remanufacturing of Medical Devices

By MedTech Intelligence Staff
FDA Logo

The guidance defines remanufacturing, includes relevant considerations to determine if activities are remanufacturing, and provides recommended labeling information to ensure serviced devices are returned to their established performance and safety specification.

May 1, 2024

FDA Releases Laboratory Developed Tests Final Rule

By MedTech Intelligence Staff
FDA Logo

“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and health care providers can trust.”

April 10, 2024

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines

By MedTech Intelligence Staff
Gavel

The consent decree restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met.

April 3, 2024

FDA to Host Virtual Workshop on ASCA Program Expansion

By MedTech Intelligence Staff
FDA Logo

On April 17, the FDA is hosting a Virtual Public Workshop on approaches to Accreditation Scheme for Conformity Assessment Expansion.

March 25, 2024

FDA Proposes Ban on Electrical Stimulation Devices

By MedTech Intelligence Staff
FDA Logo

“These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.”

March 17, 2024

FDA Outlines its Approach to Artificial Intelligence Regulation

By MedTech Intelligence Staff

“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.

February 20, 2024

FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data

By MedTech Intelligence Staff
FDA Logo

Following a “alarming” increase in medical device submissions containing unreliable data, the FDA is reminding manufacturers and study sponsors that they are responsible for qualifying third-party test labs and closely scrutinizing all testing data.

January 31, 2024

FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office

By MedTech Intelligence Staff
FDA Logo

As part of its reorganization of the CDRH, the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office that will include the Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR) and Office of Equity and Innovative Development (OEID).

TOPICS

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

Upcoming Events & Webinars

No posts found.

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 - 2026 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.

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.