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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.

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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.

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Combination product, drug, device and biologic
November 2, 2015
Combination product, drug, device and biologic

Two Key Processes You Must Know as a Combination Product Manufacturer

By David Amor

When preparing a regulatory submission, there are a couple of critical elements to consider.

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Checkbox
October 21, 2015
Checkbox

CDRH Releases 2016 Priorities

By MedTech Intelligence Staff

Leveraging big data and clinical evidence is top of mind.

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Medical devices market in Russia, Intertek
September 29, 2015
Medical devices market in Russia, Intertek

Regulatory Changes and Market Access for Medical Devices in Russia

By Mark Miska

When entering this emerging market, the benefits may outweigh any risks.

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

One, Two, Three Strikes You’re Out…Or, Receive a Warning Letter

By Dr. Christopher Joseph Devine

It is in the best interest of an offending establishment to be timely and complete in responding to Form 483 observations.

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Mika Javanainen, M-Files Corp., Hybrid cloud for medical device manufacturers
September 1, 2015
Mika Javanainen, M-Files Corp., Hybrid cloud for medical device manufacturers

Why the Hybrid Cloud is Practical for Medical Device Manufacturers

By Mika Javanainen

Cloud-based information management platforms improve collaboration without sacrificing compliance.

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August 19, 2015

How to CE Mark a Medical Device that Incorporates a Drug

By Paula McCarthy

An awareness of the European regulations and the definitions is essential when pursuing a CE Mark for a combination product.

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August 3, 2015

What Do FDA Investigators Look for During an Inspection?

By Maria Fontanazza

Getting into the mindset of an FDA investigator during an inspection is not necessarily easy.

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July 13, 2015
MEDdesign

Mobile Apps in the Medical Device Industry: Safety, Security and Patient Privacy

By Delmar Howard

There are several steps you can take to ensure your mHealth app is keeping patient health data safe and secure.

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Columns

September 13, 2023

FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility  

By MedTech Intelligence Staff
FDA Logo

The FDA has updated its guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,” to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” in pre-market applications.

August 4, 2023

The Underrated Variable of IoMT Device Security: Collaboration

By Shankar Somasundaram
Shankar Somasundaram

Healthcare cyberattacks are becoming more common and more costly—both financially and to patient care continuity. Internet-connected IoMT devices and equipment remain a security concern for healthcare delivery organizations. Deeper collaboration between HDOs, medical device manufacturers and security providers is needed to reduce risk and vulnerability.

June 14, 2023

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

By MedTech Intelligence Staff
Kaushik Gune

This week Huma Therapeutics received FDA Class II 510(k) clearance for its Software as a Medical Device (SaMD) platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with Kaushik Gune, U.S. Head of Healthcare at Huma, about the current state of digital health technologies, the value of partnerships to enhance the use of real world data and how digital health is likely to advance in the coming years.

May 16, 2023
Soapbox

Automating Computer Systems Validation for Your QMS

By Davor Milosevic, Massimo Franza
Binary code

Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.

March 27, 2023

Medical Technology and ESG: Solving the Data Problem

By Sarah Carpenter
Sarah Carpenter

Only one third of “The State of ESG in Manufacturing” survey respondents have high confidence in the quality and accuracy of their supply chain data. This article summarizes the risks of poor data, the seven elements that contribute to siloed data, and the associated regulatory risks.

March 20, 2023
Soapbox

What You Need To Know About FDA Remote Medical Device Inspections

By Steven Silverman
Steve Silverman

The Food and Drug Omnibus Reform Act (FDORA) authorized FDA to conduct remote device facility inspections. While it will take time for the FDA to take the necessary steps to start performing remote inspections, industry can look to remote regulatory assessments as a potential model.

January 18, 2023

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

FDA Logo

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.

November 16, 2022

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

FDA

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.

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  • MedTech Economics
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