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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Medical Device Software

    This session is dedicated to Medical Device Software, presenting the essentials of software qualification and classification from both the EU and US perspectives. The most relevant standards, IEC 62304 and IEC 82304, for Software Life Cycle requirements are introduced, and topics such as artificial intelligence (AI) and cybersecurity are discussed.

    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

    • Software Qualification and Classification
      • The EU perspective – the MDCG 2019-11 guidance document
      • Why does all software land in class IIa or higher in the EU, requiring a Notified Body?
      • The US FDA perspective
      • Unregulated software in hospitals – What to take into account?
    • Software Life Cycle requirements – Stand-alone and embedded SW
      • Software standards (IEC 62304 and IEC 82304-1)
      • Software safety classification according to IEC 62304
      • Medical software development and maintenance
      • Agile development from medical software point of view
      • AI/ML software in healthcare, regulatory aspects

    Target group

    All developers of medical software and stakeholders interested in gaining specific knowledge on what to take into account for the efficient commercialization of medical device software. Particular focus on start-up founders and staff, university innovator teams, young health tech professionals, and new employees.

    Objectives

    Know the specific regulatory requirements for developing safe and efficient medical device software.

    Additional information

    Following the Regulatory Essentials sessions 1-4 before this on-demand session is recommended.