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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).


Different types of ISO 13485 Audits

Different types of ISO 13485 Audits

Audits are a key component of ISO 13485:2016




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Protect Your ISO 13485:2016 Quality Management System – Mistakes to Avoid

Protect Your ISO 13485:2016 Quality Management System – Mistakes to Avoid

ISO 13485:2016 – your partial gateway towards market entry around the World!