Polarion Medical Device Solutions
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.
avaWorkflow
Management of digital templates and electronic review and approval process.
avaRisk
Comprehensive solution for a risk management process according to ISO 14971 with interfaces to development, usability, and clinical evaluation.
avaReporting
Comprehensive reporting functions for planning and implementation of tests as well as the representation of dependencies between information elements
avaFMEA
avaFMEA is an add-on for avaRisk and offers functionalities for the documentation of an FMEA.
avaClinical
Systematic execution and updating of clinical evaluation as well as integration of information from product development, risk management, and post-market surveillance.
avaPubmed
Simplified literature search for clinical evaluations thanks to automatically executed and documented searches in PubMed and PubMed Central.
avaPMCF
Efficient updating of the clinical evaluation: Preparation of PMCF Plan and PMCF Evaluation Report as well as monitoring of PMCF activities.
avaRegulatory
Efficient management of regulatory information & easy integration into product development
avaUsability
avaUsability enables digital creation and maintenance of the usability file in Polarion and allows integration of development and risk management activities.