Digital Health

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Digital health innovation evolves faster than regulation. Successfully bringing software-based medical technologies to market requires balancing innovation, compliance, cybersecurity, and clinical evidence. GSAP helps digital health companies build products that are not only innovative, but also regulatory-ready, secure, and commercially positioned for long-term success.

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How We Support Digital Health Companies

 

  • Regulatory Strategy & Market Pathways
    Regulatory strategy development and pathway assessment for digital health products, including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Clinical Decision Support (CDS), Mobile Medical Applications (MMA), artificial intelligence (AI), machine learning (ML), extended reality technologies, and software-based IVD solutions
  • Quality Systems & Digital Health Compliance
    Development and implementation of quality systems supporting digital health products, including software lifecycle, usability, risk management, privacy, information security, and cybersecurity requirements
  • Software Validation & Lifecycle Management
    Support for software validation activities throughout the system lifecycle, including computerized system validation (CSV), software compliance, and validation program development
  • Privacy, Information Security & Cybersecurity
    Implementation of privacy, information security, and cybersecurity frameworks aligned with applicable industry and regulatory requirements
  • Clinical Strategy & Clinical Evidence
    Support for clinical strategy development, medical writing, clinical submissions, study execution, monitoring, data management, auditing, training, and project management activities
  • Global Regulatory Compliance
    Preparation for regulatory submissions and compliance activities supporting digital health products in the United States, Europe, Israel, and other applicable markets