Practice

Medical Device and Technology Regulatory

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...

Press Releases

Hogan Lovells advises Osiris in US$660 million acquisition by Smith & Nephew

Washington, D.C., 13 March 2019 – International law firm Hogan Lovells has advised Osiris Therapeutics, Inc., (NASDAQ: OSIR), a developer of regenerative medicine products, in an...

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Hogan Lovells Publications

Life sciences and health care horizons 2019

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Hogan Lovells Publications

Brexit snapshot: Medical Devices

Do you hold a CE certificate of conformity issued by a UK notified body? Are your manufacturing activities, authorised representative, suppliers, customers or contracting parties located in ...

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Hogan Lovells Publications

Podcast series: False Claims Act 2018 and the road ahead Podcast

The pace of False Claims Act (FCA) litigation remained furious over the past year. Companies (and individuals) in all sectors of the economy continue to face the ever-present threat of FCA...

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Hogan Lovells Publications

FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483 Medical Device Alert

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments"...

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