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.
avaFMEA
avaFMEA is an add-on for avaRisk and offers functionalities for the documentation of an FMEA.
avaMedical StartUP! Suite
An integrated digital solution for design control documentation, regulatory requirement management and risk management activities.
avaAdverse
Automated import of safety-related information from national authority databases, digitalized data evaluation and easy integration into clinical evaluation and risk analysis
avaUsability
avaUsability enables digital creation and maintenance of the usability file in Polarion and allows integration of development and risk management activities.