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Regulatory Essentials in Health Tech: FDA

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This on-demand session gives a basic understanding of the U.S. regulations for medical and in vitro diagnostic devices. The regulatory path to the U.S. market and essential items related to the FDA and the U.S. Food and Drug Administration are reviewed.

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 >>

Topics of this session

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


Harinder Korhonen
Harinder Korhonen
Quality & Regulatory Affairs Manager
“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 the typical routes to the U.S. market and what is required in terms of contents and quality of the submission package.
  • Understand the fundamental differences between the European and U.S. regulations for medical device manufacturers.
  • Have a basic understanding of approaches by the FDA reviewers and “the U.S. way of thinking.”


Following the Regulatory Essentials sessions 1-5 before this on-demand session is recommended.

Billing and cancellation policy

Read the billing and cancellation policy for online trainings here.

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:  
The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to: 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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