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Can Design Controls Accelerate Medical Innovation?

Nov 16, 2020

Response to the pandemic fast-tracked the pace of medtech innovation. In the future, can a human-centered iterative approach to design...

Traceability Requirements in EU MDR

Nov 12, 2020

Medical device manufacturers marketing products in the EU must ensure traceability between all stages of medical...

Medtech Unfiltered - Affordable Care Act

Medtech Unfiltered: Should the Affordable Care Act be Struck Down?

Nov 10, 2020

News Editor Amanda Pedersen shares her thoughts on the Affordable Care Act as the U.S. Supreme Court hears oral...

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Telehealth Considerations for Medical Device Manufacturers During and After COVID-19

Oct 20, 2020

A deep dive into how COVID-19 has forced many healthcare providers to adopt telehealth solutions, and some legal considerations for manufacturers.

Building a Better Supply Chain Through Unique Device Identification

Oct 20, 2020

Class I medical device companies have work to do, despite the UDI enforcement delay.

Before You Throw Out That FDA Guidance on Lab-Developed COVID Tests ...

Oct 15, 2020

Beware of the legal and reimbursement implications of not seeking FDA authorization for your lab-developed COVID test, legal experts warn.

8 Important Medtech Updates from FDA

Oct 15, 2020

Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, and colleagues shared the latest medtech-related updates during The Medtech Conference’s annual CDRH Town Hall.

FDA Veteran Outlines Bold Plans to Increase Diversity in Medtech Industry

Oct 05, 2020

A Q&A with MedTech Color founder Kwame Ulmer.

Economic Operators: The EU MDR Compliance Journey for the Supply Chain

Oct 01, 2020

Manufacturers, authorized representatives, importers, and distributors will have added responsibilities under the EU MDR. Are...

What If the Affordable Care Act Is Overturned?

Sep 21, 2020

With the death of Supreme Court Justice Ruth Bader Ginsburg, legal scholars see an increased chance that the Affordable Care...

Medtech Unfiltered: Who Is Elizabeth Holmes?

Sep 17, 2020

Missed this week's Medtech Unfiltered? Here's the replay.

Has the Pandemic Impacted Medtech Regulation?

Sep 12, 2020

MD+DI explores whether crisis-time collaboration could forever change regulator-industry relationships.

Medtech in a Minute: NeuroMetrix Refunds, Big IPO News, and More

Sep 11, 2020

Pressed for time? Here's the medtech news you need most, in one minute or less.

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