Omsbar Medical Device Design Manufacturing and Regulatory Services



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Clinical Evaluation
  Clinical evaluation is mandatory for any medical device placed on the market in Europe, and is integral to the approval-to-market process in the USA.
  We believe that the terms Clinical Evaluation, Clinical Trials and User Acceptance Trials are often used interchangeably which is not the case. This causes much confusion in the eyes of the Regulatory Authorities and hence uneccessary additional expense and delay. Cost-effective and timely compliance with regulatory requirements is achieved by clearly separating and identifying the absolute requirements for these processes.
  Omsbar is experienced in assessing requirements for clinical evaluation and preparing position papers to present to Notified Bodies and Competent Authorities. We also construct clinical trial documentation for assessment by the Regulatory Authorities and provide the management structure for the Clinical Trial itself via associate organisations.