Accelerating Software Approval Through FDA’s ISTAND Pilot Program In a recent project, a customer developed innovative software designed to address an unmet need in evidence generation. The software had the potential to revolutionize the way data was collected and analyzed, offering new insights and improving decision-making processes in the healthcare industry. However, to bring this groundbreaking software to market, the customer needed to navigate the complex regulatory landscape and gain FDA approval. Situation The customer faced the challenge of securing FDA approval for its innovative software. This approval was crucial for the software to be recognized and trusted by healthcare providers and stakeholders. The customer sought to leverage the FDA’s ISTAND (Innovative Science

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