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Find Answers about Classification of your Innovation!

TIME CRITICAL SERVICES

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!

 

Check Now!

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).

LATEST INSIGHTS

Risk Management Analysis (ISO 14971:2019)

Risk Management Analysis (ISO 14971:2019)

Medical Device Manufacturers have a legal obligation to regularly maintain and perform risk management analyses.

15.7.2022

Patient information management (IFU, Labelling and Cartons)

Patient information management (IFU, Labelling and Cartons)

A ‘Label’ is the identity of the product.

15.7.2022

Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)

Unique Device Identification (UDI) & Global Unique Device Identification Database (GUDID)

It allows the identification of specific devices on the market and facilitates their traceability.

15.7.2022