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Consolidate market-specific documents, and maintain audit trails for design changes and quality issues to improve safety, speed regulatory submissions, and ensure compliance across global markets.
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Comply with regulations and industry standards like ISO 13485, ISO 9001, 21 CFR Part 11, and 21 CFR Part 820. Pre-defined templates, workflows, and reports help you achieve compliance faster and with less effort.
Resolve customer complaints and QA investigations to improve product safety and customer loyalty. Fully integrate to case management systems to leverage customer insights.
Easily and efficiently manage the entire process with the FDA. Ensure compliance and improve audit readiness by connecting early design to customer feedback and regulatory reporting.
Achieve compliance faster
using configurable templates
and digital submissions.
Gain efficiency and reduce
errors using automated
workflows and reports.
Monitor full materials disclosure and registration for compliance throughout the supply chain.
Speed your products to local and global markets while reducing the effort to achieve compliance by 30%.
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