We offer our own solutions for the documentation of processes in the form of configuration packages for Polarion based on the technical expertise of the avasis team and the wide range of experience in various projects. They can either be used as stand-alone solutions or integrated into your existing Polarion configuration. The individual configuration packages are coordinated with each other and offer interfaces to each other, so that you can manage the complexity of technical documentation and achieve the greatest possible benefit from digitalization.
Management of digital templates and electronic review and approval process.
Comprehensive solution for a risk management process according to ISO 14971 with interfaces to development, usability, and clinical evaluation.
Comprehensive reporting functions for planning and implementation of tests as well as the representation of dependencies between information elements
avaFMEA is an add-on for avaRisk and offers functionalities for the documentation of an FMEA.
Systematic execution and updating of clinical evaluation as well as integration of information from product development, risk management, and post-market surveillance.
Simplified literature search for clinical evaluations thanks to automatically executed and documented searches in PubMed and PubMed Central.
Efficient updating of the clinical evaluation: Preparation of PMCF Plan and PMCF Evaluation Report as well as monitoring of PMCF activities.
Efficient management of regulatory information & easy integration into product development