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)
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.
avaAdverse
Automated import of safety-related information from national authority databases, digitalized data evaluation and easy integration into clinical evaluation and risk analysis