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

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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Hogan Lovells Publications

FDA guidances promote greater communication to payors about medical product value Pharmaceutical and Biotechnology and Medical Device Alert

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as...

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Hogan Lovells Publications

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers Medical Device Alert

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket...

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Sponsorships and Speaking Engagements

8th Semi-Annual Risk Based Medical Device Supplier Quality Assurance Conference

Dennis Gucciardo is speaking on steps required to document supplier risk assessment in alignment with ISO at the 8th Semi-Annual Risk Based Medical Device Supplier Quality Assurance...

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