Regulatory Services

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Immunospec Corporation offers unique approach and expert CE marking consulting services to U.S.A and worldwide clients.
 With extensive experience and knowledge in IVD and Medical Diagnostic Devices, we introduce the most practical, convenient, and cost effective solutions for your CE marking projects.

We have assisted many clients with short turnaround for CE marking and certification, meeting their requirements and time lines.

   Our specialty CE marking services include:

  •    MDD-Medical diagnostic devices
  •    IVD- In vitro Diagnostic Low risk devices and
  •    Self-testing CE certification

   With strong relationships with European Authorized Representatives and Notified bodies, we handle all interaction and communications with regulatory agencies during approval process.

All can be done on an off site assistance basis. Our work is 100% guaranteed and we have 100% success rate. Let us help you obtain your CE mark for your products.

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