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Regulatory & Quality

ICU Medical Plum Pump Replacement Batteries Hit with Class I Recall ICU Medical Plum Pump Replacement Batteries Hit with Class I Recall

The batteries contain a defect that may substantially diminish how long it can be used to run the system when not plugged into AC power.

byKatie Hobbins

May 23, 2023|

2 Min Read

Elizabeth Holmes alongside her boyfriend Billy Evans, walks back to her hotel following a hearing at the Robert E. Peckham

Regulatory & Quality

Elizabeth Holmes' Impending Prison Date Elizabeth Holmes' Impending Prison Date

byAmanda Pedersen

May 23, 2023

1 Min Read

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Regulatory & Quality

Medtech in a Minute: Cook Stirs the Pot, and More Medtech in a Minute: Cook Stirs the Pot, and More

byAmanda Pedersen

May 22, 2023

2 Min Read

hospital patient on a ventilator, COVID-19 concept

Regulatory & Quality

Are Medical Device Shortage Reports Still Mandatory?Are Medical Device Shortage Reports Still Mandatory?

May 17, 2023

4 Min Read

young child in bed with a fever, and her father caring for her..png

Regulatory & Quality

Wearable Children's Thermometer May Cause Skin Burns Wearable Children's Thermometer May Cause Skin Burns

byAmanda Pedersen

May 17, 2023

2 Min Read

Dressed in black and wearing paper cutouts of the Dalkon Shield, Karen Hicks, president of the Dalkon Shield Information

Regulatory & Quality

What Controversy Highlighted the Need for Medical Device Reporting?What Controversy Highlighted the Need for Medical Device Reporting?

byAmanda Pedersen

May 16, 2023

2 Min Read

Regulatory & Quality

Philips Pays $62M to Settle China Bribery Probe

Philips Pays $62M to Settle China Bribery Probe

Sponsored Content

Achieving an Animal-Free Biological Safety Evaluation of Your Medical Device

Achieving an Animal-Free Biological Safety Evaluation of Your Medical Device

Regulatory & Quality

Report Links Regulatory Submission Characteristics & Device Recalls

Report Links Regulatory Submission Characteristics & Device Recalls

byJoseph O. Mrkonich

Pedersen POV quote graphic about risk management

Design & Engineering

Always Take the Road Less Traveled

Always Take the Road Less Traveled

byAmanda Pedersen

Close up of woman swab COVID-19 testing by Rapid Antigen Test kit and dropping reagent to cartridge at home, Home Isolation,

Throw out These COVID-19 Tests Immediately

Throw out These COVID-19 Tests Immediately

byAmanda Pedersen

UK, London, Big Ben and British flag

Regulatory & Quality

Great Britain to Delay New Medical Device Regulations

Great Britain to Delay New Medical Device Regulations

byAmanda Pedersen

Regulatory & Quality

ResMed CEO Looks Forward to Competing with Philips Again

ResMed CEO Looks Forward to Competing with Philips Again

byAmanda Pedersen

business man in handcuffs

Regulatory & Quality

Bad to the Bone: What Bone Cement Maker Became a Cautionary Tale?

Bad to the Bone: What Bone Cement Maker Became a Cautionary Tale?

byAmanda Pedersen

ISO 14001.png

Regulatory & Quality

Tegra Medical Achieves ISO 14001 Certification

Tegra Medical Achieves ISO 14001 Certification

byKatie Hobbins

Conference presentation

Regulatory & Quality

MedCon 2023 Session Highlights MDUFA V, TAP Pilot, EU MDR

MedCon 2023 Session Highlights MDUFA V, TAP Pilot, EU MDR

byKatie Hobbins

FDA NOT APPROVEd stamper and stamp, red ink with white background.png

Regulatory & Quality

Warning Letter Serves as Reminder to Device Industry

Warning Letter Serves as Reminder to Device Industry

byAmanda Pedersen

FDA approval

Regulatory & Quality

Study Suggests Increased Number of PMA Supplements Increase Recall Risk

Study Suggests Increased Number of PMA Supplements Increase Recall Risk

byKatie Hobbins

Medical Device Regulations

Are Big Changes in Store for Mobility Devices?

Are Big Changes in Store for Mobility Devices?

Continuous Glucose Monitoring system

Medicare Expands Continuous Glucose Monitoring Coverage

Medicare Expands Continuous Glucose Monitoring Coverage

byKatie Hobbins

photo of science equipment with text that reads: CDRH IN CRISIS

Regulatory & Quality

FDA's Device Program in Crisis, Outsiders Warned

FDA's Device Program in Crisis, Outsiders Warned

byAmanda Pedersen

Regulatory & Quality

Nelson Labs Obtains New Accreditation from FDA

Nelson Labs Obtains New Accreditation from FDA

Medtech in a Minute_1.png

Regulatory & Quality

Medtech in a Minute: How the Mighty Have Fallen

Medtech in a Minute: How the Mighty Have Fallen

byAmanda Pedersen

Regulatory & Quality

Philips’ Recall Seems Unending

Philips’ Recall Seems Unending

byAmanda Pedersen

Pedersens POV 4-10-23 quote about new opioid overdose prevention device.

Regulatory & Quality

Stop Hating on the Opioid Overdose Wearable

Stop Hating on the Opioid Overdose Wearable

byAmanda Pedersen

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Regulatory & Quality

Medtech in a Minute: Ex-Magellan Execs Face Fraud Charges, and More

Medtech in a Minute: Ex-Magellan Execs Face Fraud Charges, and More

byAmanda Pedersen

Lead test blood test

Regulatory & Quality

Ex-Magellan Execs Indicted on Criminal Charges Over Faulty Lead Tests

Ex-Magellan Execs Indicted on Criminal Charges Over Faulty Lead Tests

byAmanda Pedersen

China regulatory illustration

Medical Device Regulations

China Targets Intra-Ocular Lenses with Volume-Based Procurement

China Targets Intra-Ocular Lenses with Volume-Based Procurement

byAmanda Pedersen

ZimVie Mobi-C cervical disc prosthetic device

Regulatory & Quality

ZimVie's Mobi-C Wins Reimbursement in France

ZimVie's Mobi-C Wins Reimbursement in France

byAmanda Pedersen

semiconductor manufacturing

Picking A Semiconductor Aging Test Method

Picking A Semiconductor Aging Test Method

byKatie Hobbins

image, close-up of bottle of the combination narcotic opioid pain medication hydrocodone 5-acetaminophen 500, marketed under

Opioid Wearable Opens a Large Market Opportunity for Masimo

Opioid Wearable Opens a Large Market Opportunity for Masimo

byAmanda Pedersen

FDA approval

Regulatory & Quality

Abbott Continues Its Sterling 2023 with Epic Max FDA Approval

Abbott Continues Its Sterling 2023 with Epic Max FDA Approval

byKatie Hobbins

quality control failure concept illustrated by a rejection stamp

Regulatory & Quality

Getinge Gets Another CE Mark Suspension

Getinge Gets Another CE Mark Suspension

byAmanda Pedersen

operating room nurse uses a digital tablet to operate medical devices in the OR; medical device cybersecurity concept

Regulatory & Quality

Ready or Not, Here Comes Medical Device Cybersecurity Legislation

Ready or Not, Here Comes Medical Device Cybersecurity Legislation

byAmanda Pedersen

2009 was a year of turmoil for FDA's CDRH (Center for Devices and Regulation)

Regulatory & Quality

The Year Turmoil Erupted at CDRH

The Year Turmoil Erupted at CDRH

byAmanda Pedersen

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