We offer our own best practice configuration packages 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 configuration packages are coordinated with each other and offer interfaces to each other so that you can achieve the greatest possible benefit from digitalization.
Management of digital templates and electronic review and approval process.
Comprehensive reporting functions for planning and implementation of tests as well as the representation of dependencies between information elements
Faster approval and storage of documents thanks to the integrated OSLC interface between Polarion and Teamcenter.
Comprehensive solution for a risk management process according to ISO 14971 with interfaces to development, usability, and clinical evaluation.
Systematic execution and updating of clinical evaluation, scientific literature reviews, state of the art description, claim management and integration with product development, risk management, and post-market surveillance
Efficient updating of the clinical evaluation: Preparation of PMCF Plan and PMCF Evaluation Report as well as monitoring of PMCF activities.
avaFMEA is an add-on for avaRisk and offers functionalities for the documentation of an FMEA.
Simplified literature search for clinical evaluations thanks to automatically executed and documented searches in PubMed and PubMed Central.
Efficient management of regulatory information & easy integration into product development