Digital health regulation & registration2020-08-12T10:16:15+00:00

Regulation & registration in the digital health field

Medical software, cellular app or any other digital health device used for sensing, monitoring, testing, analyzing data, drawing conclusions or supporting medical staff decisions may have an impact on the health of the user and is therefore considered at the regulatory level as a medical device. And therefore strict compliance with regulatory requirements.
Software, mobile applications or any digital health product, which is in preparation for the final stages of the development process, requires proper documentation and preparation of applications for registration in the health authorities such as the FDA, European CE and the Israeli Ministry of Health.

Compliance with regulatory guidelines and requirements, including the filing of the technical file and other relevant documents, is a prerequisite for approving the registration of the digital health product in the target markets to obtain a marketing authorization. The process of registering a digital health product in the various health authorities in the world requires multidisciplinary knowledge and experience and it is often recommended to hold professional meetings with the various regulatory bodies to help people better understand the product and its purpose, and make the right decisions. Like the EMR products, the various digital health products are also categorized according to the level of risk they represent and hence the regulatory requirements will be derived accordingly. The EMR registration / digital health product process takes time, and therefore is aware of regulatory requirements while conscious, And acting on them while preparing the relevant documents can save the company valuable time and of course resources. Besides, a proper and efficient registration process, as much as possible for the “low classification” of the digital health product, will enable less stringent regulatory requirements to be achieved and, as a result, a faster and less expensive registration process.

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Regulation & registration consulting services in the digital health filed

  • Global regulatory strategy

  • Classification of medical software and digital health products

  • HIPAA, PHI, SCO2 & GDPR compliance

  • DMR, DHF Technical file

  • ISO 13485 / 21CFR 820 QMS certification

  • ISO 17025, ISO 14001, ISO 27001 & ISO 27799 certification

  • Clinical Risk Assessment and GCP

  • Courses and training on regulation, quality and registration

  • Design Review, Design Control

  • CE mark MDD/MDR registration

  • Writing policy documents

  • Digital health products registration in the global health authorities

  • Preparations and gap analysis towards external regulatory inspections

  • Technical file preparations

  • Medical device and software registration in FDA, IDE, PMA, 510K, CE

  • Validation and Verification

  • Risk Analysis for Digital Product and software

Other digital health services

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