Regulatory & Quality

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Regulatory & Quality

EU MDR Poses Challenges for Manufacturers EU MDR Poses Challenges for Manufacturers

Abhishek Gautam, MS, EMBA, executive engineer at DDL Inc, details the need to prioritize EU MDR compliance despite the deadline extension.

byBob Kronemyer

Jun 3, 2024

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1 Min Read

ACLA Sues FDA to Block New LDT Oversight ACLA Sues FDA to Block New LDT Oversight

byKatie Hobbins

Jun 3, 2024

1 Min Read

Tested coatings keep in-vivo parts and other biotech safe

Sponsored Content

The Importance of USP Class VI Testing The Importance of USP Class VI Testing

Jun 3, 2024

1 Min Read

Artificial Intelligence

What You Need to Know About the Artificial Intelligence Act What You Need to Know About the Artificial Intelligence Act

May 31, 2024

Regulatory & Quality

OptumHealth Nimbus II Pump System Identified as Class I Recall OptumHealth Nimbus II Pump System Identified as Class I Recall

byKatie Hobbins

May 31, 2024

1 Min Read

MathWorks Medical Devices Industry Manager Dr. Visa Suomi

Could Simulation Advance Your Testing Programs?Could Simulation Advance Your Testing Programs?

May 30, 2024

1 Min Read

FDA recall

Regulatory & Quality

Medtech Recall Round-Up: May 2024

Medtech Recall Round-Up: May 2024

byKatie Hobbins, Managing Editor

recall

Regulatory & Quality

Hologic BioZorb Marker Recall Identified as Class I

Hologic BioZorb Marker Recall Identified as Class I

byKatie Hobbins, Managing Editor

Medical Device Regulations

Kicking Open the Door for Electronic FDA Submissions

Kicking Open the Door for Electronic FDA Submissions

byAmanda Pedersen

Peter Wirthschaft, PhD, senior manager, medical device/IVD consultant for global public health and safety organization NSF

Regulatory & Quality

Seeing Double: What to Watch When Bringing Combination Products to the EU Market

Seeing Double: What to Watch When Bringing Combination Products to the EU Market

byHeather R. Johnson

International recognition

Medical Device Regulations

UK Government Propose International Medical Device Recognition Framework

UK Government Propose International Medical Device Recognition Framework

byKatie Hobbins, Managing Editor

Shape Memory Medical staff

New Technologies

Study Examines Use of Shape-Memory Polymer to Treat Pelvic Venous Disease

Study Examines Use of Shape-Memory Polymer to Treat Pelvic Venous Disease

Abbott's HeartMate 3 system is designed to take over the pumping function of the left ventricle, the main pumping chamber of the heart.

Abbott’s HeartMate Problems Trigger Déjà Vu

Abbott’s HeartMate Problems Trigger Déjà Vu

byAmanda Pedersen

Graphic to accompany Pedersen's POV, a weekly opinion column exclusive to MD+DI.

This Dental Device Manufacturer Sets My Teeth on Edge

This Dental Device Manufacturer Sets My Teeth on Edge

byAmanda Pedersen

TGA approval

Regulatory & Quality

Axonics F15 Recharge-Free SNM Nabs Australian TGA Approval

Axonics F15 Recharge-Free SNM Nabs Australian TGA Approval

byKatie Hobbins, Managing Editor

Plastic Syringe

Medical Device Regulations

FDA Adds Two New Chinese Manufacturers to Do Not Use Plastic Syringe List

FDA Adds Two New Chinese Manufacturers to Do Not Use Plastic Syringe List

byKatie Hobbins, Managing Editor

Masimo recall

Regulatory & Quality

Masimo Recalls Certain Rad-G Pulse Oximetry Devices

Masimo Recalls Certain Rad-G Pulse Oximetry Devices

byKatie Hobbins, Managing Editor

Image of U.S. Capitol building in Washington, DC.

Medical Device Regulations

This Medical Device Company Had to Fight for Its Rights

This Medical Device Company Had to Fight for Its Rights

FDA recall

Regulatory & Quality

Magadyne Mega Soft Pediatric Patient Return Electrode Recalled, Globally Discontinued

Magadyne Mega Soft Pediatric Patient Return Electrode Recalled, Globally Discontinued

byKatie Hobbins, Managing Editor

Trilogy Evo Ventilators

Regulatory & Quality

Philips Respironics Trilogy Evo Ventilator Recall Identified as Class I

Philips Respironics Trilogy Evo Ventilator Recall Identified as Class I

byKatie Hobbins, Managing Editor

FDA recall

Regulatory & Quality

Route 92 Medical Recalls Catheters After Distal Tip Separation

Route 92 Medical Recalls Catheters After Distal Tip Separation

byKatie Hobbins, Managing Editor

5 Things You Need to Know About FDA’s Final Rule on LDTs

5 Things You Need to Know About FDA’s Final Rule on LDTs

Diabetes

Regulatory & Quality

Tandem’s Recalled Insulin Pump App Connected to 224 Injuries

Tandem’s Recalled Insulin Pump App Connected to 224 Injuries

byKatie Hobbins, Managing Editor

FDA

Regulatory & Quality

Getinge Cardiovascular Devices Again Under FDA Microscope

Getinge Cardiovascular Devices Again Under FDA Microscope

byKatie Hobbins, Managing Editor

FDA

Regulatory & Quality

Outset Medical Nabs FDA Clearance for TabloCart

Outset Medical Nabs FDA Clearance for TabloCart

byKatie Hobbins, Managing Editor

5 Tips for Choosing a Reliable Testing Partner for Regulatory Success

"Selecting a Reliable Third-party Testing Partner: 5 Tips for Ensuring Successful Regulatory Submissions

byNick Christiano, Global Segment Leader - Biological Safety

A Slacker's Guide to Kicking Mandatory Training Deadlines in the Face

A Slacker's Guide to Kicking Mandatory Training Deadlines in the Face

byAmanda Pedersen

Beating Heart

BrioHealth Score IDE Approval for BioVAD System Trial Enrollment

BrioHealth Score IDE Approval for BioVAD System Trial Enrollment

byKatie Hobbins, Managing Editor

Vitek AST Kit

Regulatory & Quality

BioMérieux Vitek AST Kit Recall Given FDA Class I Treatment

BioMérieux Vitek AST Kit Recall Given FDA Class I Treatment

byKatie Hobbins, Managing Editor

IVD

LDT Oversight Gets Long-Awaited FDA Final Rule

LDT Oversight Gets Long-Awaited FDA Final Rule

byKatie Hobbins, Managing Editor

Esprit BTK System

Abbott Dissolving Stent Granted Earlier-Than-Expected FDA Approval

Abbott Dissolving Stent Granted Earlier-Than-Expected FDA Approval

byKatie Hobbins, Managing Editor

Regulatory & Quality

Philip Closes Out Recall Saga in the US

Philips Reaches Recall Settlement in the US

Recall

Regulatory & Quality

Elekta Disposable Biopsy Needle Recall Identified as Class I

Elekta Disposable Biopsy Needle Recall Identified as Class I

byKatie Hobbins, Managing Editor

LumiSystem

Medical Device Regulations

Breast Cancer Detection Drug-Device System Nabs FDA Approval

Breast Cancer Detection Drug-Device System Nabs FDA Approval

byKatie Hobbins, Managing Editor

Medtech in a Minute is a weekly video highlighting the top industry news of the week.

Medtech in a Minute: US Authorities Throw the Book at Philips, and More

Medtech in a Minute: US Authorities Throw the Book at Philips, and More

byAmanda Pedersen

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