State Of The Art [SOTA / SOA]

Clinical Evaluation Report (CER) State of the Art is demonstrated by inclusion of information related to the standard of care, current knowledge and available treatment options in form of device under evaluation, similar devices and alternatives of the medical field. During the literature search, SOTA specific question is framed, followed by search using various keywords and PICO strategy and report is prepared accordingly.

How to satisfy the requirements for SOTA?

By inclusion of below points in CER

  • Clinical background (patient population, medical indication etc)
  • Treatment alternatives available to medical conditions
  • Benchmark devices
  • Current status of the device/treatment and indication (current standards and applicable guidelines)

Contact us to perform literature search report writing, clinical data appraisal and analysis based on SOTA or SOA, Safety, Performance, acceptability of benefit-risk profile and undesirable side-effects, and all applicable GSPRs outlined in Annex 1 of the EU MDR article 61 and MEDDEV 2.7.1 Rev 4  which is generally accepted as best practice or benchmark for the medical condition or the treatment for which the medical device is used.

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