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Regulatory Essentials in Health Tech: Regulatory Essentials of In Vitro Diagnostics

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This on-demand session is dedicated to essentials for IVD developers, presenting the most critical IVD standards, IVD risk classes, and regulatory strategies for market entry. Some other IVD specifics are also presented, such as compiling General Safety and Performance Requirements for IVDs and Performance evaluations.

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

  • The early focus of the IVD developer
    • Is my product or software an IVD, and what is the risk class?
    • What does the risk class tell me about my path to market?
    • A glance at the most critical IVD standards
    • Your Regulatory Strategy for Market Entry
  • Other IVD specifics
    • General Safety and Performance Requirements for IVDs
    • Quality management for IVDs – What to consider?
    • Performance evaluations – What data do you need, and what sources can you use?
    • Special Risk Management Considerations for IVDs
Registrieren

Trainer

Harinder Korhonen
Harinder Korhonen
Quality & Regulatory Affairs Manager
harinder.korhonen@labquality.com
“I am a professional in regulatory affairs with a strong technical background and knowledge in a wide range of analytical techniques. During my 20+ years of career, I have gained a broad knowledge of global market needs and regulations for medical products including drugs, devices, and in-vitro diagnostics. Before joining Labquality Oy, I coordinated registration submissions to the EU, US, Asia, and Middle East Markets. I have contributed to building regulatory strategies for companies, including building, and maintaining relationships with local agents and regulatory bodies. In addition, I have acted as an internal auditor for quality systems compliant with the ISO 13485 standard, US (MDSAP) and EU regulations.“

Zielgruppe

All health tech developers and stakeholders interested in gaining crucial knowledge on how to save months in time-to-market of in vitro diagnostic (IVD) innovations and to avoid typical dead-ends due to non-compliance to IVD regulations. Particular focus on start-up founders and staff, university innovator teams, young health tech professionals, business advisors, and investors from early seed development to international scaling.

Nach diesem Training

  • Know the regulatory specifics related to in vitro diagnostics (IVD)
  • Have the know-how to apply the correct IVD regulations and standards to your innovation
  • Understand the most crucial regulatory bottlenecks and typical pitfalls in IVD business and time-to-market
  • Manage the basic terminology of the IVD regulations and standards

Hinweis

Following the Regulatory Essentials sessions 1-4 before this on-demand session is recommended.

What next?

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Regulatory Essentials in Health Tech - Full Training Series
Regulatory Essentials in Health Tech - Full Training Series

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@labquality.fi.  
Die teilnehmende Organisation kann den Teilnehmer auf Wunsch kostenlos wechseln, indem sie dies vor der Veranstaltung schriftlich an:  koulutus@labquality.fi 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.

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