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Find Answers about Classification of your Innovation!


Classification of your Innovation!


To be, or not to be?

Identify the intended purpose of your innovation and define its uses. Our experts will check if your innovation is a Borderline Medical Device or just another non-medical product!


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Regulatory Strategy


If your Innovation is a Medical Device, then we NEED to TALK!

A Regulatory strategy will create a pathway to protect your innovation with complete compliance with regulatory requirements.


Discuss with us!

Launchpad to EU/USA


Is your innovation a Medical Product in the EU/USA?

Are you sure?

Let our Experts confirm it for you!


Let's Discuss!

Borderline Medical Devices:


Medical Regulations around the world have different interpretation for different medical products. Sometimes an algorithm could be considered as a Medical Device and at times a wearable device might be a wellness product!

Do not worry, Our experts are right here to bring a solution. 

  • Defining the Product.
  • Identifying the Intended Purpose of your product.
  • Identifying regulations applicable to your product.
  • Creating a Regulatory Strategy.
  • Liaising with Notified bodies.
  • Registering your Product on different Medical Databases.
  • Market Analysis and identifying Regulatory Requirements.
  • Do you want to launch it in a different market? Contact GRS!


Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).


EU AR and EU Market

EU AR and EU Market

Operating without an EU Entity?
You could be at risk of a Product recall, Penalty or legal action!


ISO 13485 Importance

ISO 13485 Importance

When it comes to medical device manufacturing, patient safety depends on the quality and consistency of medical products.