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.
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
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
avaMedical StartUP! Suite
An integrated digital solution for design control documentation, regulatory requirement management and risk management activities.
avaUsability
avaUsability enables digital creation and maintenance of the usability file in Polarion and allows integration of development and risk management activities.