<img alt="" src="https://secure.52enterprisingdetails.com/787780.png" style="display:none;">
Skip to content
    Hero Image
    Regulatory Essentials

    Regulatory Essentials in Health Tech: The Core of the Regulatory Requirements

    This session introduces the General Safety and Performance Requirements, which are the heart of the regulation. It explains the principles of Clinical Evaluation and Risk Management for medical devices, both essential for fulfilling the manufacturer’s obligations.

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

    Topics

    • General Safety and Performance Requirements for Medical Devices
      • The heart of the regulation
    • Introduction to Clinical Evaluation
      • Related guidelines and standards, MEDDEV 2.7/1 and ISO 14155
      • Literature Reviews
      • Clinical Investigations
      • Post-Market Clinical Follow-up
      • Balancing between the necessary and the business advantage
    • Introduction to Risk Management
      • The ISO 14971 standard for Risk Management
      • The sequence of events and Risk Analysis
      • FMEA as the model for Risk Management
      • Risk mitigation
      • Benefit-Risk conclusions – balance with Clinical Evaluation

    Target group

    All health tech developers and stakeholders interested in gaining crucial knowledge on how to save months in time-to-market of health tech innovations and to avoid typical dead-ends due to non-compliance to the medical device or in vitro diagnostic regulations. Particular focus on start-up founders and staff, university innovator teams, young health tech professionals, business advisors, and investors from early seed development to international scaling.

    Objectives

    • Understand the core concepts of Clinical Evaluation, Risk Management, and the Benefit-Risk ratio to achieve and maintain the safety and efficacy of health technology.
    • Know which steps to take in product development to fulfill the General Safety and Performance Requirements.

    Additional information

    Combining this on-demand session with the Regulatory Essentials sessions 1, 2, and 4 is recommended.