Medical Writing

Medical Writing

Requirements and Proceedings for a Clinical Evaluation using Clinical Data

Starting the Process:
How we begin

  • Evaluation of the present Data
  • Definitions, Requirements and Strategies tailored to the Customers Medical Device
  • Reference to the Risk Management Demand according to EN ISO 14971
  • Implication related to the technical Product Documentation
  • Cross referencing to current Requirements of Directive 93/42/EWG and 90/385/EWG

Operating the Process: How we manage the process

  • Preselection of the potential Data Bases considered as the source for Clinical Data
  • Research of scientific and Medical Data Bases, Examination of related Literature
  • Documentation of Review and Selection Strategy
  • Cave: Quality Demands on Clinical Data extracted from Literature Research

Conducting the Process: How we make it happen

  • Selecting Sources verifying Conformity of Investigations utilizing similar Medical Devices
  • Evaluation of Lifecycle Surveillance Data
  • Detailed Examination of non-clinical Data, clinical Data and Data from ongoing Experience (GAP)
  • Significance and Evidence Level of published Evaluations
  • Outlining a Catalogue for Evaluation and Appraisal clinical Data from the Literature Survey
  • Issuing of the Survey Results

Final Step: Compiling the Clinical Evaluation Report (CER)

  • Arranging data into Framework of Evidence of Compliance with Key Requirements
  • Preparing draft CER
  • Expert in-house assessment of draft CER
  • Execution of Sponsor requested Adjustments following first Sponsor Review Cycle
  • Second Expert in-house Assessment of revised CER
  • Issuing of the Survey Results
  • Supplementary Data Recognition
  • Assimilation of Modifications after second Sponsor Review Cycle
  • Final CER Release