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Regulatory Essentials in Health Tech: Design Control and the Regulatory Environment

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This session reviews the principles of Design Control, starting from feasibility studies to Post-Market Surveillance. A brief look at the roles of the key authorities, certifiers, and test laboratories overseeing devices and manufacturers is also given.

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

Inhalt

  • Introduction to Design Control
    • From Feasibility Studies to Post-Market Surveillance
    • Design Verification and Validation
    • Transfer to production
  • Authorities, Notified Bodies, and test labs
    • Towards certification – CE-mark, FDA approval, and global market access
    • The perspective of authorities globally
    • Auditing and certification practices
    • Communicating with the authorities
  • Considerations on the Changing Global Regulations
    • Navigating the transitional periods
    • From the current EU directives to new regulations – MDR & IVDR
    • Strategies for dealing with a variety of requirements and timelines
Registrieren

Trainer

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.”

Zielgruppe

All health tech developers and stakeholders interested in gaining crucial knowledge on how to save months in time-to-market of health tech innovations and to avoid typical dead-ends due to non-compliance to the medical device or in vitro diagnostic 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

  • Will know how to control the design according to the global requirements throughout the device life cycle
  • Will understand the changing regulatory landscape, the mindset of the authorities, and the market access mechanisms in significant markets globally

Hinweis

Combining this on-demand session with the Regulatory Essentials sessions 1, 2, and 3 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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