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Regulatory Survey
 
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.
 
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