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Updates to ISO-18562:2024 - A CRO Point of ViewUpdates to ISO-18562:2024 - A CRO Point of View

Oct 9, 2024
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36 Min View
FDA recall
Regulatory & Quality
Mercury Medical Recall Neo-Tee T-Piece ResuscitatorsMercury Medical Recall Neo-Tee T-Piece Resuscitators
byKatie Hobbins
Oct 8, 2024
1 Min Read
FDA recall
Regulatory & Quality
Sentec/Percussionaire Phasitron 5 In-Line Valve Gets IFU UpdatesSentec/Percussionaire Phasitron 5 In-Line Valve Gets IFU Updates
byKatie Hobbins
Oct 3, 2024
2 Min Read
Philips
Regulatory & Quality
Philips Respironics Corrects Trilogy Ventilators Software, Use InstructionsPhilips Respironics Corrects Trilogy Ventilators Software, Use Instructions
byKatie Hobbins
Oct 2, 2024
2 Min Read
FDA recall
Regulatory & Quality
Gilead Sciences Recall Veklury for Injection 100 mg/VialGilead Sciences Recall Veklury for Injection 100 mg/Vial
byKatie Hobbins
Oct 2, 2024
1 Min Read
FDA Recall
Regulatory & Quality
Baxter Healthcare Nabs Class I Identity for ExactaMix Inlet CorrectionBaxter Healthcare Nabs Class I Identity for ExactaMix Inlet Correction
byKatie Hobbins
Oct 1, 2024
2 Min Read
People reacting to a scary movie in a movie theater.
QA/QC
This Medical Device Has a Scary History
This Medical Device Has a Scary History
Oct 1, 2024
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2 Min Read
byAmanda Pedersen
hand holding a brown envelope open to reveal a piece of paper with the text: WARNING at the top.
QA/QC
Globus Medical Expects FDA Warning Letter Will Be Resolved ‘in Short Order’
Globus Medical Expects FDA Warning Letter Will Be Resolved ‘in Short Order’
Sep 30, 2024
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2 Min Read
byAmanda Pedersen
Sponsored Content
How to Decode & Master Section 524B Cybersecurity with Open-Source
How to Decode & Master Section 524B Cybersecurity with Open-Source
Sep 26, 2024
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24 Min View
Sponsored Content
Inspecting Medical Devices at Scale with Automated Industrial CT Scanning
Inspecting Medical Devices at Scale with Automated Industrial CT Scanning
Oct 17, 2024
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1:00 EDT
FDA Headquarters
Regulatory & Quality
Fractures Form for Zimmer Biomet’s CPT Hip System
Fractures Form for Zimmer Biomet’s CPT Hip System
Sep 19, 2024
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2 Min Read
byKatie Hobbins
B. Braun Medical
Regulatory & Quality
B. Braun Medical Adds Another Infusomat Pump to 2023 Recall
B. Braun Medical Adds Another Infusomat Pump to 2023 Recall
Sep 18, 2024
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1 Min Read
byKatie Hobbins
Ivenix infusion system
Regulatory & Quality
Fresenius Kabi Ivenix Infusion System Connected to Second Recall in 2024
Fresenius Kabi Ivenix Infusion System Connected to Second Recall in 2024
Sep 18, 2024
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2 Min Read
byKatie Hobbins
Sponsored Content
How different are the EU & FDA medical device regulations?
How different are the EU & FDA medical device regulations?
Oct 24, 2024
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11:00 EDT
Tampon
QA/QC
Toxic Tampons: Fact vs Fiction
Toxic Tampons: Fact vs Fiction
Sep 16, 2024
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8 Min Read
byKatie Hobbins
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Sponsored Content
A Prescription For Security
A Prescription For Security
Sep 16, 2024
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1 Min Read
Pull-quote graphic accompanying the op-ed piece Pedersen's POV on the end of the "sexy medtech era" under the Affordable Care Act.
Medical Device Regulations
The End of Sexy Medtech: How Value-Based Care Changed the Game
The End of Sexy Medtech: How Value-Based Care Changed the Game
Sep 13, 2024
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5 Min Read
byAmanda Pedersen
Artificial Intelligence
AI-Enabled Medical Devices: Regulatory Trends in the United States & Beyond
Regulatory Trends for AI in the United States & Beyond
Sep 12, 2024
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9 Min Read
byHeather R. Johnson
Former President Donald Trump and Vice President Kamala Harris in a presidential debate at the National Constitution Center in Philadelphia, PA.
Medical Device Regulations
Healthcare Showdown: Trump and Harris Spar Over Legacy of 'Obamacare'
Healthcare Showdown: Trump and Harris Spar Over Legacy of 'Obamacare'
Sep 11, 2024
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8 Min Read
byAmanda Pedersen
Nonclinical Testing
Regulatory & Quality
Two Nonclinical Testing Laboratories Hit with Warning Letters
Two Nonclinical Testing Laboratories Hit with Warning Letters
Sep 11, 2024
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2 Min Read
byKatie Hobbins
False Claims Act
Medical Device Regulations
THD America Pay $700,000 to Resolve False Claims Act Violation Allegations
THD America Pay $700,000 to Resolve False Claims Act Violation Allegations
Sep 11, 2024
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2 Min Read
byKatie Hobbins
Compliance
Regulatory & Quality
How to Survive FDA’s Predetermined Change Control Plan
How to Survive FDA’s Predetermined Change Control Plan
Sep 10, 2024
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9 Min Read
byErez Kaminski
FDA recall
Regulatory & Quality
FDA Recall Roundup: August 2024
FDA Recall Roundup: August 2024
Sep 10, 2024
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4 Slides
byKatie Hobbins
Sponsored Content
Navigating FDA Section 524B
Navigating FDA Section 524B
Sep 9, 2024
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1 Min Read
Sponsored Content
Delivering Advancements in Medical Devices
Delivering Advancements in Medical Devices
Sep 9, 2024
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1 Min Read
Tracheostomy Tube
Regulatory & Quality
Smiths Medical Identifies Issue with Bivona Tracheostomy Tubes
Smiths Medical Identifies Issue with Bivona Tracheostomy Tubes
Sep 6, 2024
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1 Min Read
byKatie Hobbins
FreeStyle Libre 3
Regulatory & Quality
Abbott FreeStyle Libre 3 CGM Recall Designated Class I
Abbott FreeStyle Libre 3 CGM Recall Designated Class I
Sep 6, 2024
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1 Min Read
byKatie Hobbins
McGrath MAC Video Laryngoscope
Regulatory & Quality
Medtronic Issues Explosive McGrath MAC Video Laryngoscope Recall
Medtronic Issues Explosive McGrath MAC Video Laryngoscope Recall
Sep 5, 2024
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3 Min Read
byKatie Hobbins
Blood Clot
Regulatory & Quality
Six Deaths Connected to Inari ClotTriever XL Recall
Six Deaths Connected to Inari ClotTriever XL Recall
Sep 4, 2024
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2 Min Read
byKatie Hobbins
FDA Recall
Regulatory & Quality
Baxter’s Volara System Recall Gets Class I Treatment
Baxter’s Volara System Recall Gets Class I Treatment
Sep 4, 2024
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2 Min Read
byKatie Hobbins
Catheter sterile medical device
Sterilization
FDA Experts Delve into Sterilization Topics
FDA Experts Delve into Sterilization Topics
Aug 26, 2024
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3 Min Read
byKassandra Kania
PeGraphic featuring MD+DI senior editor Amanda Pedersen's headshot and a pull quote from her latest Pedersen's POV editorial.
Medical Device Regulations
'Not Going Back' to the Shultz Era of Medical Device Regulation
'Not Going Back' to the Shultz Era of Medical Device Regulation
Aug 23, 2024
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4 Min Read
byAmanda Pedersen
quality control inspector (man in a business suit) writing on a clipboard
QA/QC
That Time FDA was ‘Unusually Thorough’ on a Form 483
That Time FDA was ‘Unusually Thorough’ on a Form 483
Aug 19, 2024
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2 Min Read
byAmanda Pedersen
Artificial Intelligence
Artificial Intelligence
AI Regulations: A Priority for Medical Device Manufacturers
AI Regulations: A Priority for Medical Device Manufacturers
Aug 16, 2024
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5 Min Read
byClive Hudson
FDA
Regulatory & Quality
Globus Medical Faces FDA Ire in New Warning Letter
Globus Medical Faces FDA Ire in New Warning Letter
Aug 13, 2024
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4 Min Read
byKatie Hobbins

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