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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Biological and Electrical Safety

    This on-demand session presents the core requirements for demonstrating biological and electromedical safety for medical devices. ISO 10993 series of standards are reviewed, from material characterization to biocompatibility testing. Likewise, the IEC 60601 and its application for determining electrical safety are presented.

    The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>

    Topics

    • Biological Safety
      • MDR/IVDR perspective
      • The ISO 10993 series of standards
      • Biological Evaluation
      • External service providers for testing
    • Electrical Safety
      • The IEC 60601 series of standards, scope and applicability
      • Determining the right collateral and particular standards
      • Essential performance and product classification
      • Electromagnetic compatibility (EMC)

    Target group

    All health tech developers and stakeholders interested in gaining specific knowledge on the electrical and biological safety requirements for the efficient commercialization of electromedical and other hardware medical devices. Special focus on start-up founders and staff, university innovator teams, as well as young health tech professionals and new employees.

    Objectives

    • Know the basics for evaluating the biological safety of a medical device.
    • Understand the relationship between different standards and standard families dictating the requirements for demonstrating the electrical safety of a medical device.

    Additional information

    It is recommended to follow the Regulatory Essentials sessions 1-4 as well as sessions 8 (Risk Management) and 9 (Usability) before this on-demand session.