Topic Centers

Total Product Life Cycle

Hogan Lovells has you covered during the total life cycle of a Medical Device.
We have been there before. We know the rules. We know the regulators.

TPLC
Design & development
Premarket regulatory strategy
Distribution
Postmarket performance
Compliance & enforcement

Postmarket performance

We guide you through the health hazard evaluation process (used to determine if a field action is warranted), and the reporting and execution of global product recalls. We assist you in assessing whether adverse events and device malfunctions require reporting. We help develop and execute appropriate corrective and preventive actions to address product, quality, and regulatory issues. We assist in the negotiation and design of postmarket studies and assess real world data on device performance.

Insights and Analysis

Encyclopedia of Mineral and Energy Policy - The United States: Mining Laws Springer

June 2021

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Total Product Life Cycle

Postmarket performance

Encyclopedia of Mineral and Energy Policy - The United States: Mining Laws Springer

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