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 !
Be confidently prepared for your regulatory submission.
Speed towards approval with a software platform built for the specific challenges SxMD companies face.
Get innovative products
in market on time
Establish regulatory processes from the beginning with a connected quality and design ecosystem to keep teams on track.
Build processes to keep teams compliant
Schedule internal audits, assign tasks to team members, set due dates, and create review and approval workflows that simplify audit management.
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Maintain strong design controls
Link quality and product information to simplify the management of SOPs, technical documentation, V&V, risk, and training records throughout the entire lifecycle.
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Generate DHF or TF documentation faster
Easily generate documents in multiple formats with built-in review and approval workflows, audit trails, and Part 11 compliant eSignatures with an item-based approach to paperwork.
Prove continuous improvement
Demonstrate control and visibility across the product lifecycle with software that makes it easy to organize documentation and track any audit finding to completion.
Hear from our customers
“With automation from MatrixALM, we shortened our regulatory timeline by six months while at the same time reducing our human resources requirements by two full-time equivalents.”
Jon Giambattista, Director of Software
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