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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

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

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

Medical Device Manufacturing: Five Challenges in Maintaining Compliance

By Ajay Panwar

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.

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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

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

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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

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

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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

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

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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

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.

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Peter Rose, Maetrics
July 31, 2017
Peter Rose, Maetrics
Soapbox

A Smooth Route to the New Medical Device Regulation

By Peter Rose

The new MDR introduces several changes that manufacturers must consider right away.

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Scott Gottlieb, FDA
July 14, 2017
Scott Gottlieb, FDA

FDA’s Innovation Initiative Aims to Prevent Regulatory Barriers

By MedTech Intelligence Staff

The agency wants to modernize its regulatory processes and make them more efficient.

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Checkbox
July 5, 2017
Checkbox

Paperless Manufacturing: Five Key Benefits for Medical Device Manufacturers

By Sean O’Sullivan

Going paperless can ultimately help companies focus on improving product quality and the end-user experience.

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Theranos
June 23, 2017
Theranos

Report: Theranos to Settle $140 Million Lawsuit with Walgreens

By MedTech Intelligence Staff

The settlement is one of a few that the company has made within the past several months.

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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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