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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.


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Launchpad to EU/USA


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

Are you sure?

Let our Experts confirm it for you!


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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 AI Act and Digital Health

EU AI Act and Digital Health

Would there a major impact on Digital Health?


How to assign Master UDI-DIs to contact lenses: A new regulation update

How to assign Master UDI-DIs to contact lenses: A new regulation update

The European Commission on 20 October 2023 published an amendment which introduces a new concept of Master UDI-DI for contact lenses.


eSTAR and Pre Market Approval

eSTAR and Pre Market Approval

On 6th December 2023, the USFDA announced the voluntary use of eSTAR - Electronic Submission Template.