IEC 60601-1 standard training

We will study the basic safety and essential performance standard IEC 60601-1 , its content and requirements.

The standard is essential for manufacturers or repair shops of electrically operated medical devices. The standard covers an essential part of compliance with the EU MDR and FDA requirements.

The training is in English.

Time: 29.9. 2021, klo 9.00-16.00
Place: Teams
Price: 790€ + alv 24%

 

Target audience: Designers of medical electrical equipment (electronics / mechanics / radiation / usability / software), persons responsible for requirements, persons responsible for device risk management, persons responsible for the quality system.

After the training:

  • You will understand the standard content and know how to use it.
  • You can combine the standard with other device-specific standards.
  • You will know what are the risks that the standard requires you to consider.
  • You will know how the standard requirements will change in the near future.

Trainer:

CONTENT:

  • Why standard?
  • Standardization organizations
  • Regulatory requirements and standards
  • Main standards
  • Relationships with IEC standards
  • Introduction to IEC 60601-1
  • The future of IEC 60601-1 in brief
  • How do I read a standard
  • IEC 60601-1 requirements and tests
    • Usability
    • Software
    • Mechanics
    • Usability
    • EMC
    • Future

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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