Regulatory Essentials in Health Tech – Session 7: FDA


This session gives a basic understanding of the US regulation for medical devices and in vitro diagnostic devices.
The regulatory path to the US market and important items related to the FDA, U.S. Food and Drug Administration are reviewed.

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: 7.4.2022 at 10.00-12.30 (EET)
Place: Online
Price: 250€ + VAT 24%

AUTUMN 2022
Time: 20.9.2022
Place: Online
Price: 250€ + VAT 24%

 

Target Group:
All health tech developers and other stakeholders interested in how to enter the US market and which are the main issues to be considered when submitting a sales approval application to the FDA.

After this session, you:

  • Know which are the typical routes to U.S. market and what is required in terms of contents and quality of the submission package.
  • Understand which are the fundamental differences between the European and US regulations for the medical device manufacturer.
  • Have a basic understanding on approaches by the FDA reviewers and “the U.S. way of thinking”.

Notice: It is recommended to follow the Regulatory Essentials sessions 1-5 prior to this course.

Trainer: 


Jouni:
” I´m an experienced specialist in approvals and registrations of medical devices (MD) and quality systems. I have over 10 years in MD product development and over 10 years in quality and regulatory affairs. I have strong knowledge of safety standards for medical devices. I´m also an experienced auditor and can audit according to ISO 13485 standard. Due to my working experience with electrical devices, I have a strong background on Electromagnetic compatibility issues.”

CONTENT OF THIS SESSION:

    • Why USA?
    • What is a medical device and differences in definitions
    • Intended use
    • Major regulatory differences to EU and in quality systems
    • UDI – Unique Device Identification
    • Software products including AI
    • Costs
    • Where to get information
    • Practical lessons & stumbling blocks.

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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