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