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.

Our Solutions
Workflow
avaWorkflow

Management of digital templates and electronic review and approval process.

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avaRisk
avaRisk

Comprehensive solution for a risk management process according to ISO 14971 with interfaces to development, usability, and clinical evaluation.

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avaReporting
avaReporting

Comprehensive reporting functions for planning and implementation of tests as well as the representation of dependencies between information elements

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avaFMEA
avaFMEA

avaFMEA is an add-on for avaRisk and offers functionalities for the documentation of an FMEA.

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avaClinical
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

 

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avaRegulatory
avaRegulatory

Efficient management of regulatory information & easy integration into product development

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avaMedical StartUP! Suite

An integrated digital solution for design control documentation, regulatory requirement management and risk management activities.

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avaUsability
avaUsability

avaUsability enables digital creation and maintenance of the usability file in Polarion and allows integration of development and risk management activities.

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