Total Product Life Cycle

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.