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    Regulatory Essentials in Health Tech: Post-Market Surveillance and Clinical Follow-up

    REGULATORY ESSENTIALS

    This on-demand session gives a basic understanding of the regulation of Post-Market Surveillance (PMS) and the mandatory PMS documentation, such as the Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP).

    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

    • Purpose and definitions of PMS and PMCF
    • MDR requirements and guidelines
    • How to gather data and identify data gaps
    • PMS process and plan
    • Trend reporting
    • When and why to conduct a PMCF study
    • PMS and PMCF in relation to Clinical Evaluation
    • PMS report, Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP)
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    Trainer

    Heikki Pitkänen
    Heikki Pitkänen
    CEO & Founder, Lean Entries - Senior Expert, Regulations & Quality
    heikki.pitkanen@aurevia.com
    ”I have more than 20 years of experience in the health tech field including responsibilities in product development as well as regulatory and quality-related positions. I have worked previously at SGS as a site manager providing Medical Device manufacturers with Notified Body, accredited test lab and training services for worldwide market access. I have participated in international standardization and in the CEN-CENELEC Advisory Board for Healthcare Standards."

    Zielgruppe

    All health tech developers and stakeholders interested in gaining specific knowledge on how to take into consideration the Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) requirements for medical devices and in-vitro diagnostics to remain in compliance throughout the device life-cycle. Special focus on start-up founders and staff, university innovator teams as well as young health tech professionals and new employees.

    Nach diesem Training

    • Understand the fundamental requirements for post-market surveillance for all types of medical devices.
    • Understand the relationship of Post-Market Surveillance to Clinical Evaluation, Risk Management, and business in the long term.

    Hinweis

    It is recommended to follow the Regulatory Essentials sessions 1-4 as well as sessions 8 (Risk Management) and 11 (Clinical Evaluation) before this on-demand session.

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    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.