Build high-quality SaMD solutions with MatrixQMS.

Improve Quality, Achieve compliance and innovation in your Medical Device with a collaborative quality management system (QMS) that bridges the gap between engineering and quality teams.

Trusted by 200+ SxMD & Medical Device Industry Companies for Better Quality

Lean & agile quality management software

Take control of your processes, documents, CAPAs, training, audits, and risk management with a top quality management software made to streamline your path to market.

Digitize your quality standards and procedures in a QMS

Ensure your project meets regulatory compliance with a flexible Quality Management QMS software platform that comes with a library of quality standards and procedures.

  • Create new quality standards and procedures in a controlled manner and engage with stakeholders through direct annotations for collaborative review.

  • Access a simplified interpretation of ISO 13485:2016 standards and an exact copy of the FDA (Food and Drug Administration) Part 820 which can be linked to your procedures.

  • Easily build your gap analysis against any standard and link it to the required processes for better quality.

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 to ensure compliance.

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 integrates design control to help 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, supplier quality management, 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

Core Quality Software Features

Streamline success with key quality management system (QMS) capabilities built for the SxMD industry.

CAPAsLog corrective and preventative actions to improve quality and link them to the task in your issue-tracking software.
Gap AnalysisLink regulatory requirements from quality standards and regulations with your procedures in your quality management system (QMS).
Document ManagementReview, approve, update, and link documents with full traceability within the software platform. No third-party documentation software needed.
Training ManagementAssign training and set up workflows and due dates for individual or role-based training activities.
TemplatesCreate and approve templates in one central software solution. Assign templates to different projects in the QMS and ALM.
Compliant SignaturesRequest and collect compliant 21 CFR Part 11 signatures on any documentation so you can be prepared for your next audit.
See all features here to ensure you choose the right quality solution

Request a demo

Take a tour with us to improve quality & see how you can better document requirements, faster with Matrix Requirements, specialised in the Medical Device Industry.