Medical Device Regulations

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Navigating FDA Section 524B Navigating FDA Section 524B

The need-to-knows about cybersecurity in medical devices

Sep 9, 2024

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1 Min Read

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Delivering Advancements in Medical Devices Delivering Advancements in Medical Devices

Sep 9, 2024

1 Min Read

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

byAmanda Pedersen

Aug 23, 2024

4 Min Read

Artificial Intelligence

How to Meet Compliance Requirements for the AI Act Meeting Compliance Requirements for the AI Act

Aug 13, 2024

9 Min Read

Medical Device Regulations

Is EU MDR Worth the Hassle and Expense?Is EU MDR Worth the Hassle and Expense?

byLisette Hilton

Aug 8, 2024

6 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

byKatie Hobbins

Aug 2, 2024

2 Min Read

Spine

Life Spine Arx SAI Spinal Fixation System Nabs FDA Clearance

Life Spine Arx SAI Spinal Fixation System Nabs FDA Clearance

byKatie Hobbins

Sponsored Content

FOCUS ON FUNDAMENTALS - Vaporized Hydrogen Peroxide Sterilization: Guidance & Considerations

Vaporized Hydrogen Peroxide Sterilization: Guidance & Considerations

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

Medical Device Regulations

From Toxic to Transparent: How Shuren's Leadership Transformed CDRH

From Toxic to Transparent: How Shuren's Leadership Transformed CDRH

byAmanda Pedersen

Statistics

Medical Device Regulations

2024 Medtech FDA Approval Volume Trends Down

2024 Medtech FDA Approval Volume Trends Down

byKatie Hobbins

LDTs

Assessing Industry Impact of FDA’s LDT Final Rule

Assessing Industry Impact of FDA’s LDT Final Rule

Omnipod 5

Insulet Reports Positive Type 2 Diabetes Study Results

Insulet Reports Positive Type 2 Diabetes Study Results

byKatie Hobbins

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5 Top 21 CFR Non-Compliance Violations & How to Avoid Them

5 Top 21 CFR Non-Compliance Violations & How to Avoid Them

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

Artificial Intelligence

What You Need to Know About the Artificial Intelligence Act

What You Need to Know About the Artificial Intelligence Act

Medical Device Regulations

Kicking Open the Door for Electronic FDA Submissions

Kicking Open the Door for Electronic FDA Submissions

byAmanda Pedersen

International recognition

Medical Device Regulations

UK Government Propose International Medical Device Recognition Framework

UK Government Propose International Medical Device Recognition Framework

byKatie Hobbins

TGA approval

Regulatory & Quality

Axonics F15 Recharge-Free SNM Nabs Australian TGA Approval

Axonics F15 Recharge-Free SNM Nabs Australian TGA Approval

byKatie Hobbins

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

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

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

Esprit BTK System

Abbott Dissolving Stent Granted Earlier-Than-Expected FDA Approval

Abbott Dissolving Stent Granted Earlier-Than-Expected FDA Approval

byKatie Hobbins

LumiSystem

Medical Device Regulations

Breast Cancer Detection Drug-Device System Nabs FDA Approval

Breast Cancer Detection Drug-Device System Nabs FDA Approval

byKatie Hobbins

Pedersen's POV graphic featuring MD+DI Senior Editor Amanda Pedersen

Medical Device Regulations

Fueling the Fire of Access to Emerging Medical Devices

Fueling the Fire of Access to Emerging Medical Devices

byAmanda Pedersen

Eko Health Low EF Detection AI

Artificial Intelligence

Eko Health Nabs FDA Clearance for Low EF Detection AI

Eko Health Nabs FDA Clearance for Low EF Detection AI

byKatie Hobbins

1Q2024 Healthcare Recalls

Disturbing Healthcare Recalls in 1Q2024

Disturbing Healthcare Recalls in 1Q2024

byKassandra Kania

Jonathan Ripley

Medical Device Regulations

Ensuring Continued Availability of In-Vitro Diagnostics in UK, EU

Ensuring Continued Availability of In-Vitro Diagnostics in UK, EU

byJonathan Ripley

Medical technology

Medical Device Regulations

How Will FDA’s New QMSR Affect Medical Device Companies?

How Will FDA’s New QMSR Affect Medical Device Companies?

bySusan Shepard

Shane Farritor

Medical Device Regulations

FDA Grants De Novo Authorization for Virtual Incision Mira Surgical System

FDA Grants De Novo Authorization for Virtual Incision Mira Surgical System

byLisette Hilton

European Union Council

Medical Device Regulations

EU Council Endorse New Measures to Prevent Medical Device Shortages

EU Council Endorse New Measures to Prevent Medical Device Shortages

byKatie Hobbins

AI EU Act

Artificial Intelligence

The EU AI Act: How Will It Impact Medical Device Manufacturers?

The EU AI Act: How Will It Impact Medical Device Manufacturers?

byHeather R. Johnson

PFAS chemicals

The Coming Restrictions on Forever Chemicals

The Coming Restrictions on Forever Chemicals

What Does the EU MDR Extension Mean for Packaging?

What Does the EU MDR Extension Mean for Packaging?

byKassandra Kania

What Does the EU MDR Extension Mean for Packaging?

What Does the EU MDR Extension Mean for Packaging?

byKassandra Kania

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