Risk management is one of the most important processes in the life cycle of medical devices and must meet the requirements of the ISO 14971 standard. Information from the risk analysis is closely linked to information in the documentation of product development, usability (fitness for use), and clinical evaluation. Moreover, the risk-based approach for the validation of software tools even requires a link to the CSV process: If a software tool has a direct impact on the safety of a medical device, the associated risk determines the effort required for validation or the need for verification.
avaRisk enables you to map your risk management process digitally and link it directly to the content of the interface processes.
For the creation of the risk analysis, there are preconfigurations for different procedures, e.g. for the identification of risks or the probability of occurrence (P1/P2 and P).
Depending on your individual process, additional functions and attributes can be added, such as thematic grouping of risks (IEC 60601-1, usability, clinical risks), categories of risk control measures, assignment to products or product components.
By creating links between information in the risk analysis and interface processes, dependencies become visible and can be evaluated via traceability reports. For example, you can link risk control measures to design input requirements and demonstrate that each measure has been implemented and verified or validated.
The risk management report includes a summary of risks before and after implementation of measures as well as consistency checks to ensure that you do not miss any inconsistencies or incomplete information. Information from the benefit-risk assessment of the clinical evaluation can be directly inserted as referenced information.
avaRisk provides best practice templates based on the requirements of ISO 14971:2019 and can be used immediately. However, the content of the templates can also be individually adapted or supplemented with additional features upon request.
- Best Practice Templates according to ISO 14971:2019 for Risk Management Plan, Risk Analysis & Control as well as Risk Management Report
- Easy creation of the risk analysis via guided workflow
- Diverse display and sorting functions of the risk analysis for easy editing
- Methodical variants: Hazard analysis or definition of combination of Hazard, Hazardous Situation, and Harm
- Variations of the probability of occurrence: P1/P2 or P approach
- Categorization of risks and risk control measures
- Automatic consistency and completeness checks
- Link and traceability reports for interface processes: Development, usability, clinical evaluation, and software tool validation
- Easy reuse of information from documents of interface processes
- Administration of several risk management files Risk files in a Polarion project
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.