Clinical Evaluation

The evaluation of clinical data is not only of prime importance for the official approval process and product launch, but also for the continuing market surveillance in the field of medical devices.

The revision of the Medical Device Directives with the directive 2007/47/EC now requires even for the lowest risk class Medical Devices - manufacturer to establish Clinical Evaluation Report in its technical file. The Clinical evaluation of Clinical data may be derived from a literature review, clinical trials or a combination of both. The data should follow a certain format.

Symbiorph Clinical Trialogy has vast experience in preparation of clinical evaluation report in all class of medical device. We have successfully cleared the clinical evaluation for Drug Eluting Stents, Intra Ocular lenses, Nebulizers and may moreā€¦

We will support you with all aspects of the clinical evaluation of your products from:

  • Planning and preparation according to the directives and guidelines
  • Developing methodologies for the clinical evaluation
  • Literature research and survey
  • Provision of clinical expertise and expert opinion
  • Clinical Closure report
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