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Medical Device Regulation

Regulatory & Quality

EU MDR Challenges Spark Questions EU MDR Challenges Spark Questions

HungeroTrial’s Antal Solyom highlights the overwhelming amount of re-certification applications, noting that some notified bodies aren’t even accepting new device applications.

byKatie Hobbins, Managing Editor

Sep 26, 2023

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1 Min Read

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

Sep 20, 2023

1 Min Read

ISO 13485:2016 certification

Sequenex ISO Certification Validates Software Expertise Sequenex ISO Certification Validates Software Expertise

byLisette Hilton

Sep 15, 2023

1 Min Read

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

Sep 12, 2023

1 Min Read

Regulatory & Quality

Complete Rewrite of ISO 10993-1 Creates Industry Buzz Complete Rewrite of ISO 10993-1 Creates Industry Buzz

byHelin Raagel, Thor Rollins

Sep 11, 2023

1 Min Read

IMG_2023-09-11-094119.jpg

A Look at Updated Standards for Reusable Medical Devices A Look at Updated Standards for Reusable Medical Devices

byBob Kronemyer

Sep 11, 2023

1 Min Read

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

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Design & Engineering

Test Your Medtech Knowledge Every Tuesday

Test Your Medtech Knowledge Every Tuesday

byAmanda Pedersen

military

Regulatory & Quality

3M Nears $5.5B Combat Earplug Settlement

3M Nears $5.5B Combat Earplug Settlement

byKatie Hobbins, Managing Editor

Digital screen showing voting results, %22OK%22 in light blue letters, %22NO%22 in larger, bright red letters.png

Regulatory & Quality

Medtronic's Renal Denervation Dreams Dashed Again

Medtronic's Renal Denervation Dreams Dashed Again

byAmanda Pedersen

Telesair's Bonhawa High Flow Oxygen Therapy System

Regulatory & Quality

EU MDR Is the New FDA PMA

EU MDR Is the New FDA PMA

Matthew Burton, Strategic Development Director at IMed Consultancy

Regulatory & Quality

Unlocking Opportunities in the UK Medtech Market

Unlocking Opportunities in the UK Medtech Market

close up photograph of a clinician performing a catheter-based procedure in a cardiac cath lab

Regulatory & Quality

Behind the FDA Submission: How J&J Won a Key Approval in AF Ablation

Behind the FDA Submission: How J&J Won a Key Approval in AF Ablation

byAmanda Pedersen

Medtech in a Minute_1.png

Regulatory & Quality

Medtech in a Minute: Integra's FDA Warning Letter, and More

Medtech in a Minute: Integra's FDA Warning Letter, and More

byAmanda Pedersen

cluster of STOP signs

Regulatory & Quality

FDA Hits Integra with Warning Letter

FDA Hits Integra with Warning Letter

byAmanda Pedersen

UK, London, Big Ben and British flag

Regulatory & Quality

Medical Devices Won't Benefit from UK's CE Marking Extension

Medical Devices Won't Benefit from UK's CE Marking Extension

byAmanda Pedersen

Philips Trilogy Evo Ventilator System-1.png

Regulatory & Quality

Philips' Latest Ventilator Recall

Philips' Latest Ventilator Recall

byAmanda Pedersen

dialysis

Regulatory & Quality

Medtronic Faces Another Recall on Hemodialysis Catheters

Medtronic Faces Another Recall on Hemodialysis Catheters

byKatie Hobbins, Managing Editor

woman with a bandage after laparoscopic hysterectomy.png

Regulatory & Quality

These Once-Popular Medical Devices Drew Government Scrutiny in 2015

These Once-Popular Medical Devices Drew Government Scrutiny in 2015

byAmanda Pedersen

Recall Notice

Regulatory & Quality

Getinge’s Terrible, No Good, Very Bad 2023

Getinge’s Terrible, No Good, Very Bad 2023

byKatie Hobbins, Managing Editor

ISO 10993-17, ISO 10993-18

ISO Chemical Characterization for Medical Devices

ISO Chemical Characterization for Medical Devices

byNate Fredrick, Toxicologist – Expert Advisory Services

Axonics v. Medtronic (1).png

Medical Device Regulations

Medtronic and Axonics Back for Final Showdown

Medtronic and Axonics Back for Final Showdown

byAmanda Pedersen

Sleep Apnea Market - Sleep Apnea Masks

Medical Device Markets

Has ResMed Hit Its Peak?

Has ResMed Hit Its Peak?

byAmanda Pedersen

Steam train leaving town on Durango and Silverton Narrow Gauge Railroad.

Design & Engineering

The Little FDA Guidance That Could

The Little FDA Guidance That Could

byAmanda Pedersen

Regulatory & Quality

Illumina & Guardant Settle Trade Secret Lawsuit

Illumina & Guardant Settle Trade Secret Lawsuit

Compliance

Medical Device Non-Compliance Is Breaking the Bank

Medical Device Non-Compliance Is Breaking the Bank

Regulatory & Quality

Why Is Penumbra Playing Hide and Seek with Information?

Why Is Penumbra Playing Hide and Seek with Information?

byAmanda Pedersen

Impella 5.5 with SmartAssist Pump & Impella CP with SmartAssist Pump in Heart

Regulatory & Quality

Abiomed’s Impella Now Linked to 4 Deaths in Recent Recall

Abiomed’s Impella Now Linked to 4 Deaths in Recent Recall

byKatie Hobbins, Managing Editor

Medical technology

Regulatory & Quality

FDA Expands TAP Pilot to Include Neurological, Physical Medicine Devices

FDA Expands TAP Pilot to Include Neurological, Physical Medicine Devices

byKatie Hobbins, Managing Editor

Close-up of the word "Delayed" in red letters on an airline schedule monitor at an airport.

Thunderstuck: Penumbra's Thunderbolt Launch Delayed

Thunderstuck: Penumbra's Thunderbolt Launch Delayed

byAmanda Pedersen

Blue ink stamped %22DISCONTINUED%22 seal.png

Abbott Throws in the Trifecta Towel

Abbott Throws in the Trifecta Towel

byAmanda Pedersen

Spectrum infusion pumps

Regulatory & Quality

Baxter Infusion Pumps Hit with Another Class I Recall

Baxter Infusion Pumps Hit with Another Class I Recall

byKatie Hobbins, Managing Editor

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