NEU!! Entwickelt SxMDs mit einem strukturierten eQMS, einschließlich auditfähriger SxMD-Vorlagen, die an EU- und US-Standards angepasst sind. Mehr Erfahren!

Entwickelt qualitativ hochwertige SaMD Produkte mit MatrixQMS

Erreicht Compliance und Innovation eurer Medizinprodukt mit einer kollaborativen Lösung, die die Kluft zwischen Engineering- und Qualitäts-Teams überbrückt.

200+ SxMD & Medical Device Hersteller vertrauen bereits auf uns.

Schlankes & agiles Qualitätsmanagement

Kontrolliert zentral eure Dokumentationen, CAPAs, Schulungen, Audits und euer Risk Management.

Normen und Prozesse

Stellt sicher, dass eure Projekte die regulatorischen Anforderungen erfüllen, mithilfe einer flexiblen Softwareplattform, welche ISO 13485 umfasst.

  • Greift auf unsere umfassende Bibliothek von Normen- und Prozessvorlagen zu oder erstellt diese selbst basierend auf euren Anforderungen.

  • Erstellt problemlos eine eigene Gap Analyse für jede Norm und verknüpft sie mit den erforderlichen Prozessen.

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Risk Management aligned with ISO 14971

Implement a risk-based approach to quality and compliance with an eQMS software that enables you to quickly identify and mitigate risks and prevent quality-related failures.

  • Run a risk analysis for your processes in seconds and address potential risks to your business proactively.

  • Easily integrate your quality system with design controls for a comprehensive view of the product lifecycle for a more holistic risk assessment.

  • Manage risks related to product defects, non-compliance with quality standards, and internal processes.

Off-the-shelf structured eQMS

SxMD Templates complete with everything you need to develop compliantly to EU and US standards.

  • Save time with integrated templates that dynamically pull data from Matrix that trace to the standards that govern them.

  • Ensure regulatory approval with audit-ready templates compliant with EU and US regulations.

  • Gain clarity on best practices with a package specifically for Software as/in a Medical Device needs.

  • Speed up implementation with templates that are ready to use and fully configurable to adapt to your business’ specific needs.

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Unify Work Instructions

Support your day-to-day workflow with comprehensive Work Instructions that keep teams aligned, on track, and up-to-date with the latest information.

  • Organize your Quality processes in a single software solution the entire company can access.

  • Add new and update existing processes with a rich text editor.

  • Notify individuals, user groups, or the entire business when there are changes that need to be reviewed and ensure Quality Management.

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Experience top-quality management with a published QMS

Easily create, review, approve, and publish quality policies and procedures and work instructions in a centralized location.

  • Ensure company alignment with alerts and notifications as versions are modified.

  • Quickly see changes with a side-by-side version comparison.

  • Demonstrate your commitment to compliance with internal and external auditors.

Audit management excellence for the SaMD industry

Keep necessary documents, records, and processes organized in an electronic Quality Management System (QMS solution) to easily find and present them during audits and demonstrate consistency and quality control in your life sciences business.

  • Plan, execute, and report on internal audits to prove and drive continuous improvement and quality excellence.

  • Standardize processes in your quality management software with flexible templates that can accommodate the growing needs of your business.

  • Identify and link items that come out of an audit to a corrective action to ensure that any non-compliance or area for improvement is promptly and effectively addressed.

Change management for product quality

Control and document changes while ensuring compliance of medical device companies with quality management software that can help you get your products to market safely.

  • Automate change management with workflow automations to request approvals, notify stakeholders, and update documentation in an easy-to-use quality management software.

  • Evaluate, approve, and document changes with a quality system that helps you maintain or improve product quality and compliance.

  • Automatically trace and build an audit log showing every change that occurred for audit-ready quality control.

Industry-leading data security for better quality

Protect sensitive data from unauthorized access, breaches, and theft with a quality management system provider that is ISO 27001 certified.

  • Restrict data access to authorized personnel with role-based permissions to ensure information is only accessible to users who need it for their specific roles.

  • Ensure data integrity and availability in case of data loss due to system failures, cyber-attacks, or other incidents with the best Quality Management System (QMS) that includes robust data backup and recovery features.

  • Leverage a quality management software that is regularly updated to address new security threats and vulnerabilities along with regular security assessments.

Quality control and monitoring

Efficiently manage your critical and non-critical suppliers, manufacturers, and more in a structured way to prove your diligence and publish it in your quality management software (QMS) for company visibility.

  • Reduce administrative burden, improve quality and quickly justify to an auditor why you chose a specific vendor.

  • Ensure the origin and history of all components and materials manufacturing are documented to meet your requirements.

  • Configure existing or create new templates for your specific needs to help standardize your processes to improve quality.

MatrixALM + MatrixQMS

Gain full control of design, requirements, and technical documentation throughout the product lifecycle to improve quality while ensuring that all employees are working following the appropriate quality standards for the software as/in medical device industry.

  • Get your concepts off the drawing board and on the front line faster by boosting efficiencies that accelerate your time to market.

  • Create ultra-efficient digital workflows to replace archaic paper quality management and application lifecycle management processes.

  • Be up and running in days with quality systems that are based on the same design philosophy so it’s easy to onboard new users.

Elevated support services for rapid implementation and guidance

Go beyond the standard application support with services that can help you streamline compliance management so your team can focus on getting your software as/in a Medical Device to market.

  • Get best-in-class support from industry experts and support engineers for all your needs with a dedicated block of monthly hours that can be rolled over.

  • Request consulting services, audits of your Matrix system, cybersecurity guidance, training of new users and so much more whenever you need it.

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Hear from our customers

“With the Matrix Quality Management System We’ve cut the number of FTEs working on document control tasks by 50%, which frees our employees to focus on quality & value-added activities.”

Umesh Sharma, Head QA/RA

Kernfunktionen

Gewährleistet euren Erfolg mit essentiellen Qualitätsmanagementsystem-Funktionen, die auf SxMD zugeschnitten sind.

CAPAsErfasst korrektive und präventive Maßnahmen und verknüpft diese mit Tasks in eurer Issue Tracking Software.
Gap AnalyseVerknüpft regulatorische Anforderungen wie Normen und Regulationen mit Prozessen innerhalb eures QMS.
DokumentenverwaltungPrüfung, Genehmigung, Aktualisierung und Verknüpfung von Dokumenten mit voller Nachverfolgbarkeit innerhalb unserer Plattform. Es wird keine weitere Drittanbieter Software benötigt.
Schulungsplanung und -verwaltungSchulungen zuweisen und Fälligkeitsdaten festlegen für Einzelpersonen oder basierend auf Tätigkeitsgruppen. 
VorlagenErstellung und Genehmigung von Vorlagen an einem zentralen Ort. Ermöglicht die Nutzung verschiedener Vorlagen in unterschiedlichen Projekten sowohl im ALM als auch im QMS.
Konforme SignaturenAnfordern und Sammeln von 21 CFR Part 11 konformen Signaturen für jedes Dokument, so dass das nächste Audit mit Leichtigkeit angegangen werden kann.
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Demo anfordern

Seht euch mit uns zusammen an, wie ihr mit Matrix Requirements Anforderungen besser und schneller dokumentieren könnt.