Systematic execution and updating of clinical evaluation as well as integration of information from product development, risk management, and post-market surveillance

Systematic proof for clinical evidence and consistency to interfaces

Along with risk management, clinical evaluation is one of the most important lifecycle processes for medical devices. In order to demonstrate clinical safety and performance, clinical data must be collected, evaluated, and analyzed in Europe in sufficient quantity and quality. Not only for the initial approval, but also as part of regular post-market surveillance activities during the marketing phase. In addition to a systematic and transparent approach, the comparison of information with other processes is a particular challenge – inconsistencies can quickly creep in.

avaClinical is an innovative solution that allows you to carry out and document a systematic clinical evaluation digitally for the first time. The proof for sufficient clinical evidence is presented in a clear and comprehensible manner, making it easier for the authors of clinical evaluation plans and reports to prepare them in compliance with regulatory requirements. Notified bodies can find required contents according to MDCG 2020-13 faster and create the Clinical Evaluation Assessment Report.

The solution includes best practice templates for Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) based on MDR, Article 61 and Annex XIV as well as MEDDEV 2.7/1 Rev. 4 and MDCG guidelines. The templates can also be customized to your needs. The template for the SSCP (Summary of Safety and Clinical Performance) reflects the structure of the MDCG 2019-9 guideline

and clearly addresses individual questions of clinical evaluation via Clinical Evaluation Subjects. In CEP you can plan for each subject which data is supposed to be used for detection. Subjects can be linked to information from other processes to visualize dependencies, e.g. for product development, risk management, or marketing materials.

Each identified data set is documented individually and linked to the subject for which the data is used as evidence. This way you always maintain a clear overview, no matter how many data records you use.

The benefit-risk assessment in the CER can be easily reused in the risk management report – this way, inconsistencies do not stand a chance.

Overview of features:
  • Best Practice Templates for Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) based on MDR, Article 61 + Annex XIV, MEDDEV 2.7/1 Rev. 4 and MDCG guidelines
  • Efficient template creation through reuse of existing information
  • Connection of information with product development, risk management, post-market surveillance
  • Systematic structuring of the clinical evaluation with “Clinical Evaluation Subjects”
  • Unambiguous assignment of individual data sets to the Clinical Evaluation Subjects
  • Transparent evidence for the required clinical evidence without having to work with additional reference managers
  • Reuse of information, e.g. benefit-risk evaluation in the risk management report
Discover more Polarion solution packages

avasis solutions offers its own best practice configuration packages based on the technical expertise of the avasis team and the wide range of experience in various projects.

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Sarah Panten
Sarah Panten
Strategic Business Development