Do you need a regulatory plan before entering a new market? Do you wish to know what is the best regulatory strategy when launching your product internationally? All you need is ask us to conduct a regulatory survey for you.
What does the regulatory survey report includes?
You will receive from the Arazy Group a report, in which the rather complicated and confusing professional regulatory terms will be detailed in a clear and simple manner. The steps to be taken to get your product approved will be specified to the last detail. The survey will include:

• The classification of your product, in Europe, Canada and in the USA.
  
  
• The route for the required approval in the US (exempt, 510(k), PMA).
  
  
• The route for the required approval in Europe (ANNEX II, IV, V, VII).
  
  
• A list of the relevant topics needed to be considered in the application for the approval.
  
  
• The requirements for medical research (clinical trials), if applicable.
  
  
• Specific CE or FDA Guidance (if exist), relevant for your specific product.
  
  
• The requirements of quality control under ISO9001/ISO13485, QSR, Software Validation Standards, and all other requirements applicable to the specific device.
  
  
• A comprehensive regulatory strategy.
  
  
• List of services and terms of future collaboration with the Arazy Group.

Please remember:

• Regulation of your product is an integral part of the R&D!
  
  
• It is never too early to start the regulatory process!
  
  
• The regulatory survey report should be the first step on your path to the market.
  
  
• Developing a wise and early regulatory strategy will prove, in final analysis, to have been one of the wisest decisions you have taken to get your product sold.