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Regulatory Essentials in Health Tech: Risk Management in Practice

Home / Trainings and events / Regulatory Essentials in Health Tech: Risk Management in Practice

This session makes a practical approach to implementing 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 fourteen 2,5h webinar sessions.
Read more on the complete course page here >>

Topics of this session

  • Purpose of Risk Management
  • MDR requirements for risk management and ISO 14971 standard
  • Risk management process in practice
    • Risk analysis, estimation and control
    • Residual risks and risk management report
  • Post-market surveillance
  • Risk-management documents and tools
  • Risk management as a continuous process
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Trainers

Leena Raunio
Leena Raunio
Quality and Regulatory Affairs Manager
leena.raunio@labquality.com
”I’m an experienced regulatory affairs and quality assurance professional who has worked for a number of Medical Device manufacturers, ranging from biodegradable orthopaedic implants to medical software for the US, EU and many other markets. I hold experience from senior managerial roles in multinational regulatory and quality-related positions and I have supported many Medical Device manufacturers and other economic operators as a regulatory consultant throughout my career that spans two decades.”

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 the Risk Management of a medical device
  • Know-how to implement Risk Management in practice

Notice

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

What next?

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Regulatory Essentials in Health Tech - Full Training Series
Regulatory Essentials in Health Tech - Full Training Series

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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