Regulatory & Quality

More Topics

Medical Device Regulations

FDA Clarifies Recommendations on Cardinal Health Monoject Recall FDA Clarifies Recommendations on Cardinal Health Monoject Recall

The new letter by FDA aimed to expand the recall notice to PCA pumps, which the original recall did not mention. It’s that gap in information that concerned FDA.

byKatie Hobbins, Managing Editor

Nov 21, 2023

|

1 Min Read

Medical Device Regulations

Pulse Biosciences files 510(k) for CellFX nsPFA Percutaneous Electrode Pulse Biosciences files 510(k) for CellFX nsPFA Percutaneous Electrode

byKatie Hobbins

Nov 21, 2023

1 Min Read

Medical Device Regulations

Getting a Handle on EU MDR Getting a Handle on EU MDR

byHeather R. Johnson

Nov 20, 2023

1 Min Read

Human Factors Guidance in Combination Medical Devices 86.png

Regulatory & Quality

House Subcommittee Secures Bipartisan Vote on Faster Access to Innovative Medtech House Subcommittee Secures Bipartisan Vote on Faster Access to Innovative Medtech

byKatie Hobbins

Nov 16, 2023

1 Min Read

Human Factors Guidance in Combination Medical Devices 87.png

Regulatory & Quality

Cardinal Health Branded Monoject Syringe Recall Gets Class I Treatment Cardinal Health Branded Monoject Syringe Recall Gets Class I Treatment

byKatie Hobbins

Nov 16, 2023

1 Min Read

Chinese manufacturing photo illustration.png

Regulatory & Quality

How a Chinese Manufacturer Could Have Avoided a Warning Letter How a Chinese Manufacturer Could Have Avoided a Warning Letter

byAmanda Pedersen

Nov 16, 2023

1 Min Read

Surgical Mesh

Regulatory & Quality

FDA Warns of Mesh Use in Breast Surgery after BD Updates Labels

FDA Warns of Mesh Use in Breast Surgery after BD Updates Labels

byKatie Hobbins, Managing Editor

bronchoscopes

Regulatory & Quality

Olympus Issues Field Action for Bronchoscope Use with High-Frequency Therapy Equipment

Olympus Issues Field Action for Bronchoscope Use with High-Frequency Therapy Equipment

byKatie Hobbins, Managing Editor

McGrath Mac video laryngoscopes

Regulatory & Quality

FDA Deems Recall of Stolen Medtronic Laryngoscopes as Class I

FDA Deems Recall of Stolen Medtronic Laryngoscopes as Class I

byKatie Hobbins, Managing Editor

Attorney General

Regulatory & Quality

25 Attorney Generals Write Open Letter to FDA on Pulse Oximetry Accuracy

25 Attorney Generals Write Open Letter to FDA on Pulse Oximetry Accuracy

byKatie Hobbins, Managing Editor

Regulatory & Quality

The Problem with FDA's Warning to Abiomed

The Problem with FDA's Warning to Abiomed

byAmanda Pedersen

Diagnostic and operative laparoscopy

Regulatory & Quality

Olympus Recalls UHI-4 Insufflation Unit

Olympus Recalls UHI-4 Insufflation Unit

byKatie Hobbins, Managing Editor

Pleural Effusion

Regulatory & Quality

Pleural Dynamics Nabs FDA Clearance for ACES System

Pleural Dynamics Nabs FDA Clearance for ACES System

byKatie Hobbins, Managing Editor

Hamilton C1/T1/MR-1 ventilators

Regulatory & Quality

Hamilton Medical Ventilator Recall Deemed Class I

Hamilton Medical Ventilator Recall Deemed Class I

byKatie Hobbins, Managing Editor

Liver function

Regulatory & Quality

SeaStar Medical Nabs Breakthrough Device Designation for Hepatorenal Syndrome

SeaStar Medical Nabs Breakthrough Device Designation for Hepatorenal Syndrome

byKatie Hobbins, Managing Editor

Experimental setup used for the experiments

Study: SLSC Photoacoustic Imaging to Reduce Skin Tone Bias

Study: SLSC Photoacoustic Imaging to Reduce Skin Tone Bias

byKatie Hobbins, Managing Editor

Editorial cartoon showing an explorer deep inside a prehistoric cave, discovering a big book, with the text, %22At last he

Regulatory & Quality

FDA Guidance 2023 on ISO 10993-1: What Changed?

FDA Guidance 2023 on ISO 10993-1: What Changed?

byHelin Raagel, Audrey Turley

Stolen medical devices concept.png

Regulatory & Quality

Medtronic Isn't the First Victim of Stolen Medical Devices

Medtronic Isn't the First Victim of Stolen Medical Devices

byAmanda Pedersen

Regulatory & Quality

Another Blow Dealt in the Philips Recall Saga

Another Blow Dealt in the Philips Recall Saga

auditing process validations

Solving Problems Amid Auditing Process Validations

Solving Problems Amid Auditing Process Validations

byBob Kronemyer

Changes to CFRs Will Focus on How Manufacturers Use Risk Management

Changes to CFRs Will Focus on How Manufacturers Use Risk Management

bySusan Shepard

Medtech in a Minute_1.png

Regulatory & Quality

Medtech in a Minute: Edwards at the Center of Antitrust Accusations, and More

Medtech in a Minute: Edwards at the Center of Antitrust Accusations, and More

byAmanda Pedersen

Regulatory & Quality

Philips Scandal Is a Blight on Medtech's Reputation

Philips Scandal Is a Blight on Medtech's Reputation

byAmanda Pedersen

Image of a woman using a sleep apnea machine (CPAP) with overlaid text reading "It was a catastrophic series of errors"

Regulatory & Quality

Philips Accused of a Dangerous Secret

Philips Accused of a Dangerous Secret

byAmanda Pedersen

European Commission

Regulatory & Quality

EC Antitrust Regulators Target Edwards Lifesciences

EC Antitrust Regulators Target Edwards Lifesciences

byKatie Hobbins, Managing Editor

Medical Device Regulation

Regulatory & Quality

EU MDR Challenges Spark Questions

EU MDR Challenges Spark Questions

byKatie Hobbins, Managing Editor

Gavel with flag of the European Union in the background.png

Regulatory & Quality

European Commission Cracks Down on Medical Device Anti-Trust Activity

European Commission Cracks Down on Medical Device Anti-Trust Activity

byAmanda Pedersen

ISO 13485:2016 certification

Sequenex ISO Certification Validates Software Expertise

Sequenex ISO Certification Validates Software Expertise

byLisette Hilton, Reporter and President

Theranos, Walgreens fraud lawsuit

Regulatory & Quality

Walgreens Settles for $44M in Theranos Fraud Class-Action

Walgreens Settles for $44M in Theranos Fraud Class-Action

byKatie Hobbins, Managing Editor

ISO 10993-1

Regulatory & Quality

Complete Rewrite of ISO 10993-1 Creates Industry Buzz

Complete Rewrite of ISO 10993-1 Creates Industry Buzz

byHelin Raagel, Thor Rollins

A Look at Updated Standards for Reusable Medical Devices

A Look at Updated Standards for Reusable Medical Devices

byBob Kronemyer

Regulatory & Quality

Diving into FDA’s QMSR Alignment with ISO 13485

Diving into FDA’s QMSR Alignment with ISO 13485

Ventilators

Regulatory & Quality

Philips Reaches First Class-Action Settlement in Ventilator Lawsuit

Philips Reaches First Class-Action Settlement in Ventilator Lawsuit

byKatie Hobbins, Managing Editor

Ventilators

Regulatory & Quality

Hamilton Ventilators Used in Neonates Fetch Class I Recall

Hamilton Ventilators Used in Neonates Fetch Class I Recall

byKatie Hobbins, Managing Editor

EU MDR (Medical Device Regulation) concept.png

Regulatory & Quality

Mastering the European Medical Device Regulation Maze

Mastering the European Medical Device Regulation Maze

Sign up for the QMED & MD+DI Daily newsletter.