Clinical Evaluation Reports

Audit ready Clinical Evaluation Reports according to MEDDEV 2.7/1 Revision 4 (PDF format).

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Systematic Clinical Reviews

Rigorous systematic reviews performed using DistillerSR.

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Health Technology Reports

Assessments of the clinical/cost-effectiveness of new or existing health technologies.

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Regulatory Documents

Clinical study protocols, clinical study reports, and Investigator's Brochures.

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About Thera-Business

Thera-Business has been involved in the development of evidence-based reports and regulatory documents for over 20 years. We are experts in developing Clinical Evaluation Reports for medical devices.

We can:

  • perform comprehensive systematic literature reviews using DistillerSR
  • appraise clinical studies for suitability and data contribution
  • provide expert analysis, interpretation and summarizing of results
  • produce audit ready Clinical Evaluation Reports according to MEDDEV 2.7/1 Revision 4 Guidelines
  • perform Clinical Evaluation Report remediation
Why choose us

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We've completed 500+ projects for leading medical device and pharmaceutical companies, as well as government health agencies.