Regulatory Essentials in Health Tech – Session 5: Regulatory Essentials of In Vitro Diagnostics


This session is dedicated to essentials for IVD developers, presenting the most important IVD standards, IVD risk classes and regulatory strategy to market entry. Some other IVD specifics are presented as well, such as compiling General Safety and Performance Requirements for IVDs and Performance evaluations.

The Regulatory Essentials in Health Tech training series consists of fourteen 2,5h webinar sessions.
Read more on the complete course page here.

 


 

SPRING 2022
Time: 31.3.2022 at 10.00-12.30 (EET)
Place: Online
Price: 250€ + VAT 24%

AUTUMN 2022
Time: 13.9.2022
Place: Online
Price: 250€ + VAT 24%

Target Group:
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. Special focus on start-up founders and staff, university innovator teams and young health tech professionals, business advisors and investors from early seed development to international scaling.

After this session, you:

  • 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

Notice: It is recommended to follow the Regulatory Essentials sessions 1-4 prior to this course. 

Kouluttaja:


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.”

CONTENT OF THIS SESSION:

    • Early focus of the IVD developer
      • Is my product or software an IVD and what risk class?
      • What does the risk class tell me about my path to market?
      • A glance at the most important IVD standards
      • Your Regulatory Strategy to 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 you can use?
      • Special Risk Management considerations for IVDs

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.

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