CLINICAL APPROVAL,
CLINICAL RESEARCH ORGANISATION (CRO)
Our business activities include:

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