Medical Device Regulations

Graphic featuring a headshot of MD+DI Senior Editor Amanda Pedersen and pull quote from her Pedersen's POV opinion column.

Medical Device Regulations

EU MDR: Something's Gotta Give EU MDR: Something's Gotta Give

This week in Pedersen’s POV, our senior editor advocates for changes to the European Union’s Medical Device Regulation.

byAmanda Pedersen

Feb 5, 2024

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4 Min Read

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Understanding the EU MDR Understanding the EU MDR

Mar 7, 2024

1 Hr View

Concept illustration of the European Union Medical Device Regulation

Medical Device Regulations

When Will the EU MDR Burden Begin to Ease?When Will the EU MDR Burden Begin to Ease?

byHeather R. Johnson

Jan 29, 2024

7 Min Read

What You Need to Know About FDA's Proposed Regulation of LDTs What You Need to Know About FDA's Proposed Regulation of LDTs

Jan 26, 2024

7 Min Read

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Unique Device Identification (UDI): Regulation & Compliance 101 Unique Device Identification

Jan 24, 2024

28 Min View

Headshots of former FDA commissioners from December 1969 through July 2005

Medical Device Regulations

The Most Controversial FDA Leader in History The Most Controversial FDA Leader in History

byAmanda Pedersen

Jan 12, 2024

3 Min Read

Medical Device Regulations

ResMed's CPAP Warning Is Now a Class I Recall

ResMed's CPAP Warning Is Now a Class I Recall

FDA

Medical Device Regulations

Preparing for Quality Management System Regulation Amendments

Preparing for Quality Management System Regulation Amendments

byBob Kronemyer

Senators Dick Durbin, D-Ill, and Richard Blumenthal, D-Conn

Regulatory & Quality

FDA Facing Increased Scrutiny Over Medical Device Recalls

FDA Facing Increased Scrutiny Over Medical Device Recalls

byKatie Hobbins

Medical Device Regulations

Medtech Is Missing the Forest for the Trees in the LDT Debate – But So Is FDA

Medtech Is Missing the Forest for the Trees in the LDT Debate – But So Is FDA

byAmanda Pedersen

Medical Device Regulations

Does Your Medical Device Submission Adhere to FDA’s Cybersecurity Requirements?

Does Your Medical Device Submission Adhere to FDA’s Cybersecurity Requirements?

bySusan Shepard

graphic showing map of Europe with "EU MDR" and "Medical Device Regulation" text

Medical Device Regulations

EU MDCG Updates Controversial Position Paper

EU MDCG Updates Controversial Position Paper

byAmanda Pedersen

syringe

Medical Device Regulations

FDA Clarifies Recommendations on Cardinal Health Monoject Recall

FDA Clarifies Recommendations on Cardinal Health Monoject Recall

byKatie Hobbins

FDA

Medical Device Regulations

Pulse Biosciences files 510(k) for CellFX nsPFA Percutaneous Electrode

Pulse Biosciences files 510(k) for CellFX nsPFA Percutaneous Electrode

byKatie Hobbins

Medical Device Regulations

Getting a Handle on EU MDR

Getting a Handle on EU MDR

byHeather R. Johnson

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3 Things You Need to Know About the FDA’s QMSR Alignment With ISO 13485

3 Things You Need to Know About the FDA’s QMSR Alignment With ISO 13485

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Cyber-Safety: Practical Strategies for 524B Compliance

Cyber-Safety: Practical Strategies for 524B Compliance

Axonics v. Medtronic (1).png

Medical Device Regulations

Medtronic and Axonics Back for Final Showdown

Medtronic and Axonics Back for Final Showdown

byAmanda Pedersen

Medical Device Regulations

No, Elizabeth Holmes Did Not Dupe the Prison System

No, Elizabeth Holmes Did Not Dupe the Prison System

byAmanda Pedersen

Medical Device Regulations

FDA Focuses on Modernizing Clinical Trials

FDA Focuses on Modernizing Clinical Trials

Man in business suit making the time out gesture with his hands.

Medical Device Regulations

Illumina's FTC Trouble Dates Back Further than You Think

Illumina's FTC Trouble Dates Back Further than You Think

byAmanda Pedersen

Patient undergoing cataract surgery.png

Medical Device Regulations

Expectations of VBP on the Chinese Ophthalmic Market

Expectations of VBP on the Chinese Ophthalmic Market

byAmanda Pedersen

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

Medical Device Regulations

Are Big Changes in Store for Mobility Devices?

Are Big Changes in Store for Mobility Devices?

Medtech in a Minute_1.png

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

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

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

Apple Watch vs AliveCor Kardia band.png

Apple vs. AliveCor and the Evolution of Wearable Medical Devices

Apple vs. AliveCor and the Evolution of Wearable Medical Devices

byWilliam Betten

Medical Device Regulations

Roadblocks Still Exist in Transition to IVD Regulation

Roadblocks Still Exist in Transition to IVD Regulation

Terry Mahn, US Technical Advisor for CISPR/B Senior Principal, Fish & Richardson

Medical Device Regulations

This Company’s False Compliance with CISPR 11 Resulted in a $12 Million FCA Fine

This Company’s False Compliance with CISPR 11 Resulted in a $12 Million FCA Fine

ZimVie Struggles to Find Its Footing Post-Spin

ZimVie Struggles to Find Its Footing Post-Spin

byAmanda Pedersen

Scott Gottlieb, MD, former commissioner of FDA, testifies during a House Energy and Commerce Committee hearing concerning

Medical Device Regulations

Former FDA Head Wants WHO to Tighten Health Laws

Former FDA Head Wants WHO to Tighten Health Laws

byAmanda Pedersen

An EU flag, flown by anti-Conservative and anti-Brexit activists, flaps in the air in front of the Elizabeth Tower, commonly

Regulatory & Quality

The Bumpy Road to MDR

The Bumpy Road to MDR

New Report Forecasts Impact of Medical Device Coatings 54277

New Report Forecasts Impact of Medical Device Coatings

Chinese currency shown in the background with a gavel and the China flag, and a downward arrow representing the impact of

Medical Device Regulations

China's VBP Regulation Impacts Medtronic Sales

China's VBP Regulation Impacts Medtronic Sales

byAmanda Pedersen

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