Matrix Quality (formerly Simploud) empowers life sciences and medtech organizations to streamline compliance, enhance collaboration, and accelerate innovation while maintaining strict regulatory rigor. It replaces fragmented spreadsheets and legacy systems with a single source of truth for all quality activities. The cloud-based platform is highly flexible, scalable, and secure, designed to grow with your organization. Featuring pre-configured workflows and built-in dashboards, it provides real-time visibility into quality metrics, significantly reducing validation efforts and ensuring audit readiness at a moment's notice.
A startup from Germany.
Document Control
Streamline document creation, revision, approvals, and electronic signatures in compliance with FDA 21 CFR Part 11.
CAPA Management
Automate corrective and preventive action workflows to log, track, and resolve quality non-conformances fast.
Audit & Training Tracking
Plan and record internal audits while automating employee training logs to maintain constant inspection readiness.
Global medical device manufacturers (MDMs)
Innovative Software as a Medical Device (SaMD) startups
Healthcare IoT and digital health solution providers
Regulatory consulting firms and quality audit organizations
Biotechnology, IVD, and life sciences research institutes
Matrix Quality is built specifically for medical device manufacturers and life sciences companies rather than general business sectors. It seamlessly integrates digital document controls, CAPA workflows, internal audits, and training tracking to ensure complete FDA 21 CFR Part 11 and ISO 13485 compliance out-of-the-box, removing the risk of manual administrative errors.
Traditional QMS solutions are often clunky, heavily siloed, and require months of expensive custom implementation. Matrix Quality offers a modern, collaborative, cloud-native platform that is easy to deploy and intuitive to use. It keeps engineering and quality teams aligned in real-time, automating inspection readiness without slowing down product development.
The primary audience consists of Quality Assurance (QA) managers, Regulatory Affairs (RA) directors, compliance officers, and medical device manufacturers (ranging from innovative startups to established enterprise brands) who need to streamline quality operations and maintain continuous audit readiness.
Matrix Quality was developed by Matrix Requirements, founded in Germany in 2014 by Yves Berquin and Wolfgang Huber. After helping countless medical device companies automate technical design controls and requirements engineering, they expanded their industry expertise to digitize quality management systemsโreimagining paper-based quality processes into highly integrated, cloud-native compliance workflows.
Matrix Quality is a modern SaaS platform designed with enterprise-grade security and scalability. Built on reliable web architectures, it features robust end-to-end data encryption, electronic signatures (FDA 21 CFR Part 11), automated audit logging systems, and secure API layers that support flexible connections with developer environments and compliance toolchains.
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