Regulatory Essentials in Health Tech – Session 2 Early Development and Management

This session wraps up the must-know issues to consider in early development of your innovation. How to demonstrate the compliance to applicable regulation and how to build up a Quality Management System (QMS) which ensure that devices consistently meet the requirements for safety and performance?

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

Time: 7.9. 2021, at 10.00-12.30 (CET 9.00-11.30)
Place: Zoom
Price: 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, young health tech professionals, business advisors and investors from early seed development to international scaling.

After this session, you:

  • Know what to take into account regarding regulations and standards from the early stage of product development
  • Have a view on the medical device life cycle from early development to post-market actions
  • Know what to consider when planning your Quality Management System (QMS)

Notice: It is recommended to combine this session with the Regulatory Essentials sessions 1, 3 and 4. For more specific knowledge and hands-on approach to ISO 13485 and QMS requirements it is recommended to follow the one day ISO 13485 -course.



    • Early development stages
      • Timelines and the Medical Device Life Cycle
      • Capturing the Value Proposition
      • Early validation through Feasibility Studies
      • Preparing for Design Control and Post-Market activities
      • Assigning roles and responsibilities in-house and externally
      • Document and records management, logs and traceability
    • Building your Quality Management System (QMS)
      • ISO 13485 and other international QMS related standards
      • Management responsibility
      • From planning to operations – Ensuring consistently safe and efficient devices
      • Supplier Control – From supplier evaluation to contracts and partnership
      • Importer and Distributor relations

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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