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CLINICAL APPROVAL,
CLINICAL RESEARCH ORGANISATION (CRO)

Our business activities include:

  • Pre-clinical and clinical evaluations
  • Clinical Study/Investigation
  • Post Market Surveillance (PMS), Vigilance, Post Market Clinical follow-up (PMCF)
Doctor in front of screens

Pre-clinical and clinical evaluations

We ensure that the qualification and competence for performing a clinical evaluation are given:

  • Analysis of your products degree of innovation and relevant clinical risks
  • Feasibility study for product development
  • Identification and evaluation of equivalent devices - also for 510(k) applications at the FDA
  • Creation of a Clinical Evaluation Plan and a market approval strategy
  • Performance of a clinical evaluation in accordance with MEDDEV 2.7/1 Revision 4 including the clinical evaluation report (CER)
  • Scientific literature search on the planned application (Indication, prevalence, state of art of therapy and diagnosis)
  • Scientific literature search on equivalent devices
  • Assessment of the relevance (PICO) and methodological quality of the clinical data gained
  • Inclusion and evaluation of Post Market Surveillance Data
  • Sound standing consultation for the decision to conduct a clinical investigation/study
  • Analysis of the clinical data and evaluation of the conformity with the relevant essential principles (safety, performance, benefit/risk relation, side effects)

Clinical Study/Investigation

Our experienced CRO consultants organize for you and support you with:

  • Defining the objectives and hypotheses of a clinical investigation/study according to EN ISO 14155
  • Conduction of different study types (PMCF, IIT, Pivotal trials, reimbursementstudies)
  • Preparing the necessary (minimum) technical documentation
  • Establishing the study site and interfaces
  • Drafting contracts and organizing insurance coverage
  • Obtaining initial approval for a clinical study
  • Project management of the clinical investigation incl. budget management
  • Constant monitoring as well as supervision and coordination between the involved parties
  • Ensuring test documentation, data management and data safety
  • Surveillance of compliance according regulatory requirements
  • Evaluation of data resulting from clinical investigations taking statistic, biometric and other aspects into account 
  • Drafting or reviewing the clinical investigation report
  • Medical Writing considering relevant data, regulatory requirements and current formats

Post Market Surveillance (PMS), Vigilance, Post Market Clinical follow-up (PMCF)

We document the safety and benefits of your medical device:

  • Conducting the annual market surveillance with monitoring of the schedule
  • Analysis of the clinical evaluation, the risk management file and the usability engineering files for their on-going validity
  • Collection, assessment and reporting of incidents
  • Drafting of “Field Safety Notices (FSN)”, “Field Safety Corrective Action (FSCA)” Plan (Article 89 MDR)
  • Post-market surveillance report as per Article 85 MDR
  • Drafting and maintaining the periodic safety update report as per Article 86 MDR
  • Scientific literature research as a continuation of the clinical evaluation regarding new insights from literature and regarding the safety and benefits of the product being evaluated
  • Research of current professional association guidelines and official information
  • Analysis of incidents reported to the manufacturer for the product and comparable products according to MEDDEV 2.12-1
  • Market observation research through international databases
  • Risk assessment regarding reported incidents
  • Support in deciding on the need for post-market clinical follow-up studies


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