Digital Health

    Digital Health

    The Digital health revolution is already here. the development of groundbreaking technologies together with the COVID-19 pandemic gives rise to many digital health solutions. The vision of the digital health strategy as published by the Israeli Ministry of Health (MOH) is to “enable a leap in the healthcare system so that it will be a sustainable, advanced, innovative, renewable and constantly improving the health system, by leveraging the best available information and communication technologies”. As for any medical product, digital health products must obtain specific regulations in order to bring their product from concept to reality without compromising on safety and efficacy. With years of experience in the field of medical devices, Gsap provides quality, regulation, validation, and clinical services for the digital health industry in order to bring the product in the shortest time and maximum quality to the patient.

    quality assurance medical

    Quality

    Establishment of a quality system for digital health devices.

    Our Quality services include:

    Writing quality procedures for design and development according to ISO 62304

    Processes for privacy, information security, and cyber security according to HIPPA, GDPR, ISO 27001, ISO 27799

    Risk management according to ISO 62304, IEC 60601-1

    General safety and Usability according to IEC 62366-1

    fda approved

    Regulatory

    Defining regulatory routes for the USA, European and Israeli markets, for the various products.

     

    Software as Medical Device (SaMD)

    Extended reality products

    Clinical Decision Support (CDS)

    Software in Medical Device (SiMD)

    IVD – In Vitro Diagnostics

    Machine learning (ML)

    Artificial intelligence (AI)

    MMA – Mobile Medical Application

    cro

    Clinical

    We offer clinical strategy development, medical writing, submissions, and clinical trial initiation, execution and monitoring, data management, auditing, training, and project management.

    learn more about our CRO services at the following link:

     

    CRO

    Global submission

    Navigate your product development towards market compliance

    • USA

      FDA

      Regulations:
      ●21CFR820
      ●HIPAA and relevant FDA, including the “Center of Excellence” guidance

    • Europe

      Europe

      ●Competent Authority and Notified Bodies (NB)
      ●GDPR

    • Israel

      MOH