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Labquality provides FDA Sales approval training, which will help you understand the US health tech market so that you can access the market with your own products.


Entering a new market can be challenging as you may not be aware of all the required steps that need to be taken to ensure streamlined market entry.
Labquality’s experts have the know-how to provide you with information on how to enter the US market.

There are several different market pathways you can take when seeking sales approval in the US. Labquality’s experts can also teach you:

How to classify your product?  How to find predicate devices?  What is an exempt device?

When entering a new market, it is important to understand the most important recognised standards and non-recognised standards.
Even finding the relevant information on the FDA website can be challenge, so Labquality’s experts can guide you through the entire process.


Efficient introduction – Regulatory Essentials in Health Tech – training series >>

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