Medical devices:
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Comprehensive counseling (in all topics mentioned below)
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Organizing and conducting personalized and group trainings
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Planning preclinical studies:
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In accordance with the applicable harmonized standards
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Or according to individual needs
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Composition of clinical study documentation:
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Protocol (investigation plan) writing
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Compilation of investigator’s manual
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Data management planning
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Case report form (CRF / eCRF)
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Preparation of statistical analysis plan (SAP)
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Compilation of clinical study report
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Conducting a full regulatory authorization for a clinical trial
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Compilation of technical documentation:
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Clinical evaluation (according to MDD / AIMD and MDR)
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Compilation of further elements of the technical documentation
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CE marking
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Coordination of post-marketing surveillance activities
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Compiling reports based on a market monitoring plan
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Consulting on renewal of CE marking, all kinds of related services
In vitro diagnostic (IVD) devices:
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Performance evaluation test / report
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Compilation of technical documentation