Our Solutions
Polarion Medical Device Solutions
Digital processes for the medical device life cycle
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.
All Solutions
Product Development
Quality Management
Risk Management
Usability Engineering
Clinical Evaluation
Post-market Surveillance (PMS)
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, scientific literature reviews, state of the art description, claim management and integration with 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