Skip to content
    de
    Fortbildung

    Regulatory Essentials in Health Tech: Biological and Electrical Safety

    REGULATORY ESSENTIALS

    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 >>

    Inhalt

    • 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)
    Registrieren

    Trainer

    Karri Airola
    Karri Airola
    Senior Expert, Regulations, Quality & Training
    karri.airola@aurevia.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@aurevia.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.”

    Zielgruppe

    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.

    Nach diesem Training

    • 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.

    Hinweis

    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.

    Was als nächstes?

    Sie könnten interessiert sein an

    Regulatory Essentials in Health Tech - Full Training Series
    Weiterlesen

    RECHNUNGS- UND STORNIERUNGSBEDINGUNGEN

    Lesen Sie hier die Abrechnungs- und Stornierungsbedingungen für Online-Schulungen.

    Die Teilnahme an der Schulung kann zwei Wochen (14 Tage) vor der Veranstaltung kostenfrei storniert werden. Bei Stornierungen, die danach erfolgen, berechnen wir 50 % der Teilnahmegebühr, bei Stornierungen, die eine Woche vor der Veranstaltung erfolgen, berechnen wir 100 % der Teilnahmegebühr.

    Stornierungen erfolgen immer schriftlich an: koulutus@aurevia.com.  
    Die teilnehmende Organisation kann den Teilnehmer auf Wunsch kostenlos wechseln, indem sie dies vor der Veranstaltung schriftlich an:  koulutus@aurevia.com meldet. Die Teilnahmegebühr wird unmittelbar nach der Veranstaltung in Rechnung gestellt. Die Trainingseinheit wird dem Teilnehmer ca. eine Woche vor der Veranstaltung per E-Mail bestätigt. Labquality behält sich das Recht vor, die Schulung aufgrund einer zu geringen Teilnehmerzahl abzusagen.