Regulatory Essentials in Health Tech – Session 7 Risk Management in Practice

This session makes a practical approach to implement risk management according to ISO 14971:2019 standard. Stages of risk management as well as evaluation principles are presented.

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

Time: 23.9. 2021, at 10.00-12.30
Place: Zoom
Price: single session 250€ (Prices are VAT 0%)

 

Target Group: All health tech developers and stakeholders interested in gaining specific knowledge on how to apply Risk Management for medical devices. Special focus on start-up founders and staff, university innovator teams as well as young health tech professionals and new employees.

After this session, you:

  • Know the basic requirements and terminology regarding Risk Management of a medical device
  • Know-how to implement Risk Management in practice

Notice: This session is intended to provide the basic understanding on Risk Management of medical devices. It is recommended to follow the Regulatory Essentials sessions 1-4 prior to this course. For more specific knowledge to Risk Management it is recommended to follow the one day ISO 14971:2019 risk management course.

Kouluttaja:

CONTENT OF THIS SESSION:

    • Purpose of Risk Management
    • MDR requirements and ISO 14971 standard
    • Fundamental Risk Management concepts
    • Stages of Risk Management process
    • Risk analysis, evaluation and control in practice
    • Residual risks and Risk Management Report
    • Risk Management throughout the product life cycle

BILLING AND CANCELLATION POLICY 
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: koulutus@labquality.fi.  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: koulutus@labquality.fi. 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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