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A European Authorised Representative/EC Representative is crucial for CE marking of medical and in-vitro diagnostic instruments under the current MDR and IVDR regulations. It is a requirement for any country outside of the EU If you do not have one, it is not possible to sell your products in the EU. We will help you understand the responsibilities associated with these obligations.
We guarantee the highest level of professionalism and civility in all our interactions. This is stated in our standard service contract, or in the event that you wish to or require it, in a particular confidentiality agreement that we have signed by you.
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