Regulatory & Quality

A Q&A with MedTech Color founder Kwame Ulmer.

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

With the death of Supreme Court Justice Ruth Bader Ginsburg, legal scholars see an increased chance that the Affordable Care Act is overturned. What will this mean for medtech?

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

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

In March, NeuroMetrix and its CEO agreed to pay nearly $4 million to FTC for the refunds and the company agreed to stop making the allegedly deceptive claims about the pain relief device.

The Marlborough, MA-based company has received CE mark for the fourth generation Vercise Genus Deep Brain Stimulation System.

FDA is building a web-based tracker that displays the progress of a medical device marketing submission throughout the agency's review process. The agency is seeking industry feedback on the features and information medical device companies would...

Regulation in China of AI and software in life sciences is still developing in response to rapid tech advances. Will a shift in regulatory focus in China from point-in-time registration to whole-of-life scrutiny impact AI device approval?