Eliminating Compliance Bottlenecks: AI’s Role in Streamlining Regulatory Approvals
In today’s rapidly evolving healthcare technology landscape, ensuring compliance with regulatory standards is more critical—and more complex—than ever. For innovators building Software as a Medical Device (SaMD), Digital Therapeutics (DTx), or connected medical devices, navigating the maze of regulatory requirements can become a significant bottleneck, slowing down innovation and time-to-market. This is where Artificial Intelligence (AI) steps in as a transformative force. The Compliance Challenge Healthcare software companies face intense scrutiny from regulatory bodies like the FDA, EMA, and others worldwide. These regulations are essential for patient safety, but they often demand extensive documentation, validation, and testing—processes that are time-consuming, manual, and prone to error. Powering Innovation with SaMD Validation At Akra, we are powering innovation with Software as a Medical Device (SaMD) validation using AI-driven tools that simplify and accelerate the compliance ...