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
    • EU MDR and IVDR Resource Center
    • Medical Device Labeling Resource Center
    • Medical Device Audits, Certification & Verification
    • Medical Device Component
    • Medical Recall Resource Center
    • Quality & Regulatory Market Access Solutions Resource Center
  • Events & Webinars
  • Library
FDA Logo
January 18, 2023
FDA Logo

FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices

No Comments

The FDA is hosting a webinar on February 2 for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices.

Continue reading →

FDA
November 16, 2022
FDA

FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions

No Comments

The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” in FDA documents, as well as how the agency intends to interpret existing references to section 201(h) of the FD&C Act in guidance, regulatory documents, communications and other public documents.

Continue reading →

Renato Rjavec
November 2, 2022
Renato Rjavec

Preparing for a Data-first Regulatory World

By Renato Rjavec
No Comments

As data, rather than document-based dossiers, become the focus for regulatory processes, regulatory affairs managers need to consider whether team skill sets need to be refreshed to reflect new ways of working.

Continue reading →

Peter O‘Blenis, Evidence Partners
August 31, 2022
Peter O‘Blenis, Evidence Partners

Streamlining the Literature Review Process

No Comments

Peter O’Blenis, CEO of Evidence Partners, discusses the growing role—and challenges –of literature reviews in the medtech market.

Continue reading →

Etienne Nichols, Greenlight Guru
March 24, 2022
Etienne Nichols, Greenlight Guru
Soapbox

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols
No Comments

New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.

Continue reading →

Ajay Panwar, Medtronic
September 30, 2021
Ajay Panwar, Medtronic
MEDdesign

Medical Device Manufacturing: Five Challenges in Maintaining Compliance

By Ajay Panwar
No Comments

The industry struggles with various unknowns that impact efficiency, quality, and as a result, finances. This article reviews some of these challenges and how to overcome them.

Continue reading →

Brian Moan, Norman Rabin, Maetrics
March 14, 2018
Brian Moan, Norman Rabin, Maetrics
Soapbox

IVDR signals In Vitro Industry Shake-up

By Brian Moan, Norman Rabin
No Comments

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

Continue reading →

Dr. Christopher Joseph Devine, President, Devine Guidance International
November 16, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The DMR: It’s the Recipe, People

By Dr. Christopher Joseph Devine
No Comments

The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.

Continue reading →

Dr. Christopher Joseph Devine, President, Devine Guidance International
October 25, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Dr. D Sees a Trend

By Dr. Christopher Joseph Devine
No Comments

There really is no excuse for receiving a Form 483 observation for management review.

Continue reading →

Emmanuel Garnier, Simmons & Simmons LLP
August 11, 2017
Emmanuel Garnier, Simmons & Simmons LLP
Soapbox

When Health-Related Apps Qualify as Medical Devices in the European Union

By Emmanuel Garnier
No Comments

According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.

Continue reading →

Upcoming Events & Webinars

No posts found.



On Demand Events & Webinars

No posts found.

FST's COVID-19 Resource Center



Topic Archives

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

Column Archives

  • Ameing for Asia
  • Ask the Engineer
  • CAPA Corner
  • Devine Guidance
  • From The Editor’s Desk
  • MEDdesign
  • Reimbursement Report
  • Soapbox

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 - 2023 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 settings.

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.