Regulatory & Quality

A coherent QA strategy with clearly defined resource allocation will make healthcare solutions meet the highest standards in terms of usability, security, and interoperability.

Paperless device history records could streamline operations and readily capture data, easing access anytime, anywhere.

End-user surveys offer a cost-effective approach for assembling evidence for post-market clinical follow-up.

The Osaka, Japan-based company gained access to the DE-128 device when it acquired Innfocus for about $225 million in 2016.

Device manufacturers of CAS systems should keep abreast of the changing legal issues.

The device is part of the Carlsbad, CA-based company’s MIS Ultra Suite of products.

CVRx's BeAT-HF study represents a major turning point in heart failure therapy and ushers in a new era for breakthrough medical devices.

As medical device companies use the extra time to respond to the COVID-19 pandemic, what efforts could continue to ensure MDR compliance by May 2021?

It’s exciting to start a company with a new medical device. Don’t let that excitement get in the way of planning.

Invitae is set to acquire Boulder, CO-based ArcherDx in a deal valued at $1.4 billion. As a result of the news, shares of Invitae soared on Tuesday.