Regulatory Essentials in Health Tech – Session 10: Biological and Electrical Safety


This session presents the core requirements for demonstrating the biological and electromedical 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 14 webinar sessions, 2,5h each.
Read more on the complete course page here.


 

SPRING 2022
Time: 3.5.2022 at 10.00-12.30 (EET)
Place: Online
Price: 250€ + VAT 24%

AUTUMN 2022
Time: 29.9.2022
Place: Online
Price: 250€ + VAT 24%

 

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 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 sessions 8 (Risk Management) and 9 (Usability) prior to this course.

Trainer:


Karri: 
”I have more than twenty years of experience from 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 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 his 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:
 ”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.”

CONTENT 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)

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.

Pin It on Pinterest

Jaa sivu