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.
Schlankes & agiles Qualitätsmanagement
Kontrolliert zentral eure Dokumentationen, CAPAs, Schulungen, Audits und euer Risk Management.
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.
Implement a risk-based approach to quality and compliance with an eQMS 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.
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.
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.
Keep necessary documents, records, and processes organized in an electronic Quality Management System (QMS) to easily find and present them during audits and demonstrate consistency and quality control in your business.
Plan, execute, and report on internal audits to prove 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.
Control and document changes while ensuring compliance 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.
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 a 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.
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.
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.
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.
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
Gewährleistet euren Erfolg mit essentiellen Qualitätsmanagementsystem-Funktionen, die auf SxMD zugeschnitten sind.