Team Lead, Quality and Regulatory Affairs
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.
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.