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Regulatory Essentials in Health Tech: Biological and Electrical Safety

Home / Trainings and events / Regulatory Essentials in Health Tech: Biological and Electrical Safety

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

The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>

Topics of this session

  • Biological Safety
    • MDR/IVDR perspective
    • The ISO 10993 series of standards
    • Biological Evaluation
    • 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)
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Trainers

Karri Airola
Karri Airola
Senior Expert, Regulations, Quality & Training
karri.airola@labquality.com

”I have more than twenty years of experience in the Medical Device industry in various positions, with responsibilities for leading a quality assurance team and overall regulatory compliance according to the ISO 13485 standard, Brazilian (ANVISA), Australian (TGA), US FDA and the EU MDR requirements. I have also worked in the Management Representative role for various companies and most recently as a Person Responsible for Regulatory Compliance (PRRC).

My responsibilities have also spanned the design and development of new Medical Devices, their immaterial property rights (IPR) and supply management. I have worked in start-ups and growth companies for most of my career, holding also the role of a co-founder, which has provided me with a wide perspective into the challenges that young companies face on their way to the international market.”

Ilona Santavaara
Ilona Santavaara
Senior Expert, Regulations & Quality
ilona.santavaara@labquality.com
”I have worked in regulatory compliance positions for 15 years. Prior to stepping into the Medical Device field, I held responsibilities in consumer electronics and environmental and material compliance and continue to advise manufacturers on those topics. For the past seven years, I have been guiding various health tech companies with Medical Device regulations. My experience ranges from the compliance of artificial intelligence (AI) medical software to hands-on clinical evaluation, and from setting up and auditing ISO 13485 compliant quality management systems to enabling the international market access for several types of health technology.”

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 electromedical 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 between 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 sessions 8 (Risk Management) and 9 (Usability) before this on-demand session.

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

Read the billing and cancellation policy for online trainings here.

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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