Regulatory Essentials in Health Tech – Session 3 The Core of the Regulatory Requirements

This session introduces the General Safety and Performance Requirements, which is the heart of the regulation and explains the principles of clinical evaluation as well risk management for medical devices, both being elementary for fulfilling the manufacturer’s obligations.

The Regulatory Essentials in Health Tech training series consists of eleven 2,5h webinar sessions.
Read more on the complete course here.

Time: 9.9. 2021, at 10.00-12.30
single session 250€ (Prices are VAT 0%)


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 medical device or in vitro diagnostic regulations. Special focus on start-up founders and staff, university innovator teams and young health tech professionals, business advisors and investors from early seed development to international scaling.

After this session, you:

  • 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

Notice: It is recommended to combine this session with the Regulatory Essentials sessions 1, 2 and 4.



    • 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

Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

Cancellations are always made in writing to:  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.

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