QA/QC

People reacting to a scary movie in a movie theater.

This Medical Device Has a Scary History This Medical Device Has a Scary History

Trivia Tuesday: What medical device was involved in a scary recall 10 years ago and has been involved in multiple recalls again this year, albeit for different reasons?

byAmanda Pedersen

Oct 1, 2024

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1 Min Read

hand holding a brown envelope open to reveal a piece of paper with the text: WARNING at the top.

Globus Medical Expects FDA Warning Letter Will Be Resolved ‘in Short Order’Globus Medical Expects FDA Warning Letter Will Be Resolved ‘in Short Order’

byAmanda Pedersen

Sep 30, 2024

1 Min Read

Toxic Tampons: Fact vs Fiction Toxic Tampons: Fact vs Fiction

byKatie Hobbins

Sep 16, 2024

1 Min Read

quality control inspector (man in a business suit) writing on a clipboard

That Time FDA was ‘Unusually Thorough’ on a Form 483 That Time FDA was ‘Unusually Thorough’ on a Form 483

byAmanda Pedersen

Aug 19, 2024

1 Min Read

FDA Update Plastic Syringe Safety Communication FDA Update Plastic Syringe Safety Communication

byKatie Hobbins

Jul 22, 2024

1 Min Read

Graphic illustrating hot topics in the medtech industry in July 2024 (Masimo proxy fight, JD Vance's medical investments, ventilator recalls, etc)

5 Things Medtech Is Talking About in July 5 Things Medtech Is Talking About in July

byAmanda Pedersen

Jul 18, 2024

1 Min Read

Photo Hamilton Medical's Hamilton-G5 medical ventilators

Could Better Software Testing Have Prevented a Death?

Could Better Software Testing Have Saved a Life?

byAmanda Pedersen

spiral-bound book of Code of Federal Regulations (CFR)

Top 5 CRF 21 Non-Compliance Citations – and How to Avoid Them

Top 5 CRF 21 Non-Compliance Citations – and How to Avoid Them

byAmanda Pedersen

Graphic featuring MD+DI Senior Editor Amanda Pedersen for her weekly medtech opinion column, Pedersen's POV.

The Cost of Greed in Medtech

The Cost of Medtech Greed

byAmanda Pedersen

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

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

FDA

Regulatory & Quality

Getinge Cardiovascular Devices Again Under FDA Microscope

Getinge Cardiovascular Devices Again Under FDA Microscope

byKatie Hobbins, Managing Editor

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

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

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

Abbott HeartMate 3 heart pump (left ventricular assist device) designed to help the heart pump blood to the rest of the body.

14 Deaths Connected to Latest Abbott HeartMate Recall

14 Deaths Connected to Latest Abbott HeartMate Recall

byAmanda Pedersen

Philips FDA compliance

Philips Faces Consent Decree that Restricts Sales of New Sleep Apnea Devices

Philips Faces Consent Decree that Restricts Sales of New Sleep Apnea Devices

byKatie Hobbins, Managing Editor

Medical Device Recall

Regulatory & Quality

Medos’ Cerenovus Cerebase DA Guide Sheath Recall Categorized as Class I

Medos’ Cerenovus Cerebase DA Guide Sheath Recall Categorized as Class I

byKatie Hobbins, Managing Editor

FDA device recall

Regulatory & Quality

Smith Medical Recalls PneuPac paraPAC Plus 300 and 310 Ventilator Kits

Smith Medical Recalls PneuPac paraPAC Plus 300 and 310 Ventilator Kits

byKatie Hobbins, Managing Editor

Pedersen's POV graphic feature MD+DI Senior Editor Amanda Pedersen, author of Pedersen's POV, a weekly opinion column on medtech

Medtech Lessons in the Boeing 737 Max Debacle

Medtech Lessons in the Boeing 737 Max Debacle

byAmanda Pedersen

plastic syringe

BD Increases US Syringe Production After FDA Warnings on China-Made Syringes

BD Increases US Syringe Production After FDA Warnings on China-Made Syringes

byKatie Hobbins, Managing Editor

Product of China rubber stamp

Quality Issues Involving China-made Plastic Syringes ‘More Widespread’ Than FDA Thought

Quality Issues Involving China-made Plastic Syringes ‘More Widespread’ Than FDA Thought

byNorbert Sparrow

Experts Discuss Space Manufacturing

Your Next Medical Device Could Be Manufactured in Space

Your Next Medical Device Could Be Manufactured in Space

byJamie Hartford

Medtech in a Minute graphic

Medtech in a Minute: A Not-So-Hip FDA Warning, and More

Medtech in a Minute: A Not-So-Hip FDA Warning, and More

byAmanda Pedersen

Philips stopped making the Panorama 1.0T HFO MRI systems in 2014, but about 340 of the MRI machines are still in use globally.

Philips Warns MRI Customers of Potential Explosion

Philips Warns MRI Customers of Potential Explosion

byAmanda Pedersen

Quality Alert

FDA Advises Against Use of China-Made Plastic Syringes after Quality Failure Reports

FDA Advises Against Use of China-Made Plastic Syringes after Quality Failure Reports

byKatie Hobbins, Managing Editor

Changes to CFRs Will Focus on How Manufacturers Use Risk Management

Changes to CFRs Will Focus on How Manufacturers Use Risk Management

bySusan Shepard

Regulatory & Quality

Diving into FDA’s QMSR Alignment with ISO 13485

Diving into FDA’s QMSR Alignment with ISO 13485

Check list

Achieving Medical Device Quality Management System Excellence

Achieving Medical Device Quality Management System Excellence

Coloures Pic_image001.jpg

The World of Quality Control Has Changed for Medical Device Manufacturers

The World of Quality Control Has Changed for Medical Device Manufacturers

byMichael Simms, Stefan Siwiecki

Albéa Manufactures Plastic Parts for Diagnostic Tests and More Supplier News

Albéa Manufactures Plastic Parts for Diagnostic Tests and More Supplier News

quality compliance

Struggling with Quality Compliance? This Pilot Study Is for You

Struggling with Quality Compliance? This Pilot Study Is for You

byAmanda Pedersen

Three Ways Healthcare QA Helps Improve Patient Outcomes

Three Ways Healthcare QA Helps Improve Patient Outcomes

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