Regulatory & Quality

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B. Braun Medical
Regulatory & Quality
B. Braun Medical Adds Another Infusomat Pump to 2023 RecallB. Braun Medical Adds Another Infusomat Pump to 2023 Recall

The correction, which centers on faulty occlusion alarms, now includes three Infusomat products.

byKatie Hobbins
Sep 18, 2024
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1 Min Read
Ivenix infusion system
Regulatory & Quality
Fresenius Kabi Ivenix Pump Sees Second Recall in 2024Fresenius Kabi Ivenix Pump Sees Second Recall in 2024
byKatie Hobbins
Sep 18, 2024
2 Min Read
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Sponsored Content
How different are the EU & FDA medical device regulations?How different are the EU & FDA medical device regulations?
Oct 24, 2024
11:00 EDT
Tampon
QA/QC
Toxic Tampons: Fact vs FictionToxic Tampons: Fact vs Fiction
byKatie Hobbins
Sep 16, 2024
8 Min Read
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Sponsored Content
A Prescription For SecurityA Prescription For Security
Sep 16, 2024
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 GameThe End of Sexy Medtech: How Value-Based Care Changed the Game
byAmanda Pedersen
Sep 13, 2024
5 Min Read
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
|
1 Min Read
Sponsored Content
Delivering Advancements in Medical Devices
Delivering Advancements in Medical Devices
Sep 9, 2024
|
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
Artificial Intelligence
How to Meet Compliance Requirements for the AI Act
Meeting Compliance Requirements for the AI Act
Aug 13, 2024
|
9 Min Read
byOmar Ford
Vivo 45 LS Ventilator
Regulatory & Quality
Breas Medical Initiates Vivo 45 LS Ventilator Correction
Breas Medical Initiates Vivo 45 LS Ventilator Correction
Aug 12, 2024
|
2 Min Read
byKatie Hobbins
EU MDR
Medical Device Regulations
Is EU MDR Worth the Hassle and Expense?
Is EU MDR Worth the Hassle and Expense?
Aug 8, 2024
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6 Min Read
byLisette Hilton
Medtronic NIM Vital Nerve Monitoring System
Regulatory & Quality
Medtronic NIM Vital Nerve Monitoring System Correction Deemed Class I
Medtronic NIM Vital Nerve Monitoring System Correction Deemed Class I
Aug 7, 2024
|
1 Min Read
byKatie Hobbins
Infusion
Regulatory & Quality
Smiths Medical Corrects CADD-Solis Software
Smiths Medical Corrects CADD-Solis Software
Aug 7, 2024
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1 Min Read
byKatie Hobbins
Canyon Labs' new accelerated aging chamber
Packaging
Medical Device Testing Lab Acquires Accelerated Aging Chamber
Medical Device Testing Lab Acquires Accelerated Aging Chamber
Aug 2, 2024
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2 Min Read
European Commission
Medical Device Regulations
European Medicines Agency Unveil Orphan Medical Device Pilot Program
European Medicines Agency Unveil Orphan Medical Device Pilot Program
Aug 2, 2024
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2 Min Read
byKatie Hobbins
Spine
Surgical
Life Spine Arx SAI Spinal Fixation System Nabs FDA Clearance
Life Spine Arx SAI Spinal Fixation System Nabs FDA Clearance
Jul 31, 2024
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1 Min Read
byKatie Hobbins
Sponsored Content
FOCUS ON FUNDAMENTALS - Vaporized Hydrogen Peroxide Sterilization: Guidance & Considerations
Vaporized Hydrogen Peroxide Sterilization: Guidance & Considerations
Aug 20, 2024
|
1 Hr View
Checklist
Regulatory & Quality
What Devices Made FDA's Naughty List in July?
What Devices Made FDA's Naughty List in July?
Jul 26, 2024
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7 Slides
byKatie Hobbins
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Medical Device Regulations
Medtech in a Minute: Big Collabs, and a High-Profile Retirement
Medtech in a Minute: Big Collabs, and a High-Profile Retirement
Jul 26, 2024
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1 Min Read

Editors' Choice

Masimo CEO Joe Kiani speaks from a podium with the Masimo logo in the background on a screen.
Business
Masimo's Fate To Be Decided ThursdayMasimo's Fate To Be Decided Thursday
Sep 18, 2024
4 Min Read
B. Braun Medical
Regulatory & Quality
B. Braun Medical Adds Another Infusomat Pump to 2023 RecallB. Braun Medical Adds Another Infusomat Pump to 2023 Recall
byKatie Hobbins
Sep 18, 2024
1 Min Read
Ivenix infusion system
Regulatory & Quality
Fresenius Kabi Ivenix Pump Sees Second Recall in 2024Fresenius Kabi Ivenix Pump Sees Second Recall in 2024
byKatie Hobbins
Sep 18, 2024
2 Min Read
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