Practice

Medical Device Law

Bringing a medical device to market involves addressing a host of issues: regulatory approval, patents, financing, manufacturing, distribution, and more. After your product debuts, the challenges continue throughout its life cycle, from running compliance programs to responding to enforcement actions. And if you’re operating globally, the last thing you want to do is to oversee a patchwork of different firms in different locations.

Hogan Lovells Publications

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are...

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Hogan Lovells Publications

CDRH's Voluntary Malfunction Summary Reporting Program Medical Device Alert

On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part...

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Sponsorships and Speaking Engagements

Master Class: Medical Device Clinical Research: The Path From Concept to Approval (Part 2)

Lina Kontos is a speaker in the Master Class: Medical Device Clinical Research: The Path From Concept to Approval (Part 2) session at the Magi's Clinical Research Conference - 2018 West on...

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Published Works

Three reasons attys should learn a foreign language Law 360

Attorneys who have mastered foreign languages quickly realize that their unique talent makes them stand out in their profession, and the skill is something that helps them across practice...

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Hogan Lovells Publications

Digital health: Understanding the new responsibilities facing life sciences companies related to collecting and processing personal health data under the GDPR

In May 2018, the General Data Protection Regulation (GDPR) entered into effect in EU member states, replacing a longstanding and less rigorous data and e-privacy directive. Not only does...

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Published Works

Wearable Medical Devices Raise Issues for Physicians South Florida Legal Guide

Counsel Stephanie Carman authored an article titled: "Wearable Medical Devices Raise Issues for Physicians" for the South Florida Legal Guide. 

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