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Certifications

Clinical trials and registration

Both milestones need detailed and early preparation and a sound risk mitigation strategy. With our know-how and our experience a successful registration becomes the final stage of your product development efforts but not a development hurdle.

 

  • CE Mark and FDA Registration

    -  We advise you on registration strategies, prepare your certification and compile relevant documents.

  • Quality Management

    -  We align and optimise your processes to your operational needs and strategic objectives.

  • ISO Certification

    -  On the basis of ISO requirements and your existing operations we develop optimal processes for your certification.

  • Organisation of Clinical Trials

    -  We compile market and registration requirements and plan and manage your clinical trials.