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Regulatory Essentials in Health Tech: FDA

Home / Trainings and events / Regulatory Essentials in Health Tech: 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 >>

Topics of this session

  • Why the USA?
  • What is a medical device and the 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.
Register

Trainers

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.“

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 the 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 medical device manufacturers.
  • Have a basic understanding of 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.

What next?

You might also be interested in 

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

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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