avaRegulatory
Designed for regulatory affairs teams who want to invest their time in evaluating regulatory information rather than managing it.
Download product info avaRegulatory
...extensive time investment
Valuable expertise gets bogged down in administrative activities. Regulatory teams spend a large part of their working time administering documents!
...high effort
A single normative change can affect numerous documents.
...ongoing maintenance
New regulatory documents are constantly being created and put a strain on resources.
…increased risk of errors
Regulatory authorities and notified bodies often complain about deficiencies in the submitted documentation.
These challenges can be drastically improved or even completely solved by digitalized processes!
Find out more about avaRegulatory in our on-demand webinars.
Introducing avaRegulatory 2.0
avaRegulatory 2.0 brings Regulatory Surveillance, Regulatory Intelligence, Regulatory Compliance and Regulatory Change Management together in a single, truly digitalized platform in Polarion.
Getting Smart in Regulatory Information
Learn how organizations can leverage SMART standards technology to streamline their regulatory requirements management, from importing requirements directly from external databases to implementing them seamlessly into development projects.
The digital future of regulatory requirements
In this webinar you get an overview of the new SMART standard format and existing services for the automated import of regulatory information from an external database. Moreover, the potential of AI and Large Language Models (LLM) are discussed. Last but not least, it is demonstrated, how the individual information units of a standard can be evaluated in a digitalized way, followed by efficient integration and traceability in requirements engineering as well as verification and validation documentation.
Medical device safety – there are many regulations in place to ensure this. We support manufacturers in implementing standards and other regulatory documents and, with avaRegulatory, also offer an interface to DIN Media's Nautos platform.
