Regulatory Essentials in Health Tech – Session 9 Biological and Electrical Safety

This session presents the core requirements for demonstrating the biological and electrical safety for medical devices. ISO 10993 series of standards are reviewed from material characterization to testing of biocompatibility. Likewise, the IEC 60601 and its application for determining electrical safety is presented.

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

Time: 30.9. 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 the electrical and biological safety requirements for the efficient commercialization of electromedicals and other hardware 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 basics for evaluating the biological safety of a medical device
  • Understand the relationship of different standards and standard families dictating the requirements for demonstrating the electrical safety of a medical device

Notice: It is recommended to follow the Regulatory Essentials sessions 1-4 as well as the session 7 (Risk Management) and 8 (Usability) prior to this course.

Kouluttaja:

CONTENT OF THIS SESSION:

    • Biological Safety
      • MDR/IVDR perspective
      • The ISO 10993 series of standards
      • From material characterization and Risk Management to biocompatibility testing
      • External service providers for testing
    • Electrical Safety
      • The IEC 60601 series of standards, scope and applicability
      • Determining the right collateral and particular standards
      • Essential performance and product classification
      • Electromagnetic compatibility (EMC)

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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