Nouveauté ! Développez votre produit SxMD avec un eQMS structuré comprenant des modèles SxMD prêts à être audités et conformes aux normes EU et US. En savoir plus !
Meet regulatory standards with agile development.
Remove regulatory burden with a software platform built for SxMD that enables software development while supporting rigorous compliance.
Agile release cycles without compromising quality
Drive faster, compliant product development from the start with full traceability that highlights irregularities before they become problems.
Move confidently through V&V activities
Identify and react to issues earlier with a traceability matrix that enables you to trace a requirement down to the individual test results to ensure there are no gaps or missing info.
Agile risk mitigation with ISO 14971 alignment
Easily generate an up-to-date risk management file and verify all risks are analyzed and controlled throughout the development process to mitigate downstream delays.
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Embrace agile quality management with an eQMS
Upgrade routine design or process changes with digital approval workflows that boost efficiency of vital regulatory compliance activities and pave the way for future growth.
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Work in your agile tools with powerful integrations
Develop with confidence and transfer data seamlessly between your platforms to ensure every stage has been fulfilled, is compliant and approved without duplicating efforts.
Drive rapid innovation
Change is inevitable in medical device innovation. Easily manage change in requirements and design with end-to-end traceability throughout the development process.
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Hear from our customers
“Without question, MatrixALM has helped us to shift our attitude to development: we’re now very test-driven. Our commitment to quality doesn’t come at the expense of agility. With workflow automation from MatrixALM, we can import thousands of test cases from our third-party provider and continuous integration service in just one hour—95% faster than if we were performing the same work by hand.”
Jeff Miller, VP of Engineering
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