Best Medical QMS Software

For highly regulated industries like life sciences and pharma, industry-specific quality management systems (QMS) address the complex product development lifecycle of pharmaceutical, biotech, and medical devices products. Medical QMS—also referred to as medical device QMS or QMS for life sciences—is designed to facilitate compliance with regulations enacted by the FDA and standards like ISO 13485 (the International Organization for Standardization specific to medical devices). Additionally, with a medical QMS, life science businesses can eliminate paper-based quality processes, improve product quality and safety, reduce overall costs, increase operational efficiency, and unify and standardize processes, documentation, and communication.

If you are looking for a quality system that facilitates the standardization and maintenance of standard operating procedures (SOP) or internal business processes, take a look at the healthcare compliance software. Additionally, some horizontal quality management software solutions can be, and are, used for less complicated quality processes for pharmaceutical, biotech, and medical device products.

To qualify for inclusion in the Medical QMS category, a product must:

  • Provide product traceability functionality
  • Track and document every event and process that occurs during the product lifecycle
  • Monitor industry regulation and set up reminders or triggers for potential violations
  • Capture customer complains to assess and manage risk
  • Facilitate product testing and inspections
  • Provide support and workflows for corrective actions to tested products
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    Greenlight Guru is the only quality management platform designed specifically for medical device companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control and more. Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and acheive True Quality. For more information or to request a demo, visit

    (24)4.2 out of 5
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    Qualio is modern quality management software (QMS) that unites your team, tools, and data. Designed for life sciences companies (medical device, pharma, biotech, and contract organizations) who develop, produce and distribute life-saving products and services. Crush Audits Always be audit-ready with full visibility and control over what's happening anywhere in your system. Quickly identify issues and close gaps to ensure activities are scheduled and completed on time. Eliminate Defects Identify and resolve issues before they become problems. Powerful reporting and alerts help identify problems early so that you can react quickly. Collaborate to investigate root causes and complete CAPAs in record time. ... and see Quality-Driven Growth Enjoy quality-driven growth through happy customers, reduced product issues, fast time-to-market, real-time visibility and control, rapid revenue growth and a healthy bottom line. Achieve 100% FDA/ISO/GxP compliance in audits. Qualio automates the painful paperwork and processes required by regulators for 2x faster accreditation/approval. Work 5x faster than paper/traditional solutions to manage Document Control, Training, NCRs, CAPAs, Audits, Suppliers, Complaints and more.

    CEBOS provides enterprise wide quality management and management system standard software and services.

    Quality & Project Management for achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success. qmsWrapper integrates 5 separate software into 1 complete cloud based system, including Project, Risk, Document and Quality Management modules with built-in Team Messaging for the best Collaborative Compliance experience. Quality managers with little experience can easily step into the role and effectively start. Create safer, better, medical devices and get them to market faster.

    PRISYM Medica is an enterprise labeling solution for medical device and life sciences organizations, specifically designed to meet international compliance requirements such as the FDA's labeling guidelines including 21CFR part 11.

    VRS is an interoperable solution used to manage the acceptance, formatting and delivery of the verification requests and responses. The built in look-up directory (LD) enables the proper routing of the verification requests and is synchronized across the VRS ecosystem.

    Almond® is a tool for managing the development of medical devices, that can save up to 2 years in the design and development process of medical device products; all in a secure cloud environment.

    Maintaining the highest quality levels, and a strict state of control and regulatory compliance not only affects the bottom line, it can literally be matters of life and death for medical device manufacturers.

    FFReporting Sales Force Automation (SFA) provides various features which also helps to propel your business.

    HemaComply Equipment Manager is maintenance software for scientific labs. It oversees the scheduling, review, and documentation of preventative maintenance activities to ensure equipment compliance and to support safe products and services.

    Inventory Management is a single, integrated inventory management solution that provides laboratories with all of the features and functions that are needed to effectively and efficiently manage any and all types of materials.

    The iLAB Laboratory Execution System (LES) provides QA/QC laboratories with a structured platform that eliminates paper while automating and controlling testing procedures.

    InSilicoTrials works with Pharma & Medical Devices companies to create a secure cloud-based computational hub in an easy & cheap way

    Cloud-based Electronic Device History Record software with integrated modules that manage documents, inventory, and quality assurance together with the device history records. The software will guide you through the workflows required for manufacturing medical device Class II and Class III products.

    Maetrics is a global life sciences consulting firm focused exclusively on regulatory, quality and compliance solutions for Medical Device, Diagnostic, Pharmaceutical and Biotechnology companies.

    The QMS Standard for Emerging Businesses. MasterControl Spark automates and accelerates critical quality processes from product concept to commercialization, on one integrated platform—built to scale as your business grows!

    Quality Management Systems, Requirements, Risk & Test Management for Medical Devices.

    Medicity Explore is a set of solutions bring order to both clinical and claims data, to quickly access information and use it as a strategic asset to improve cost, quality, and patient health.

    Pepper Cloud is the commercial content hub for life sciences marketing, providing organizations with all they need to create, review, manage, and analyze content across the enterprise.

    A leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries.

    Priority Pharma, an innovative end-to-end ERP solution developed to meet the unique needs of the pharmaceutical manufacturing industry.

    Q-Pulse Product Management (QPM) is a suite of applications that help manage quality inspection and process management tasks involved in bringing new products to market. They are used by manufacturers of all sizes and industries to streamline their processes, remove variation and mistake-proof important and complex tasks.

    Medical device manufacturers for biotech and pharmaceutical companies like you must be meticulous in your development process and perform comprehensive healthcare software testing and medical software validation and verification. QualiTest's teams of domain experts, focused on safety and compliance, use their high-quality healthcare testing services and medical software verification and validation services, so that hospitals, medical labs and patients can use your products. Our accelerators, pre-built environments, TCoE's and automation help with testing speed and thoroughness.

    Protecting your patients and getting your medical devices to market starts with a strong quality and compliance management system. This software and services guide you through the entire process, ensuring you have a best-practice system which meets the most rigorous compliance requirements.

    Siemens PLM Software offers solutions for leading companies in the medical device and pharmaceutical industries that recognize the need for a product lifecycle management (PLM) platform to answer product development challenges.

    SOFTDMS is an enterprise DMS that helps to control & distribute the SOP's , STP's, BMRs, Protocols and other regulated documents for pharmacies.

    A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management. Of all QMS regimes, Pharma Soft Sol Quality Management System Software deals with quality and sustainability and their integration.

    Spine BMS facilitates to manage all business disciplines including HR, Purchase, Inventory, Production Planning & Control, QA, Machine Management, Sales, Export- Import, Supply Chain, Sales Force Automation, Financials & Accounts.

    THINQ Compliance Manager is a requirements-based software with full linking and traceability for compliance content management for life sciences.

    ValGenesis, Inc. is the leading provider of paperless validation lifecycle management software solutions, designed to provide the foundation for compliance-based validation activities for Life Sciences companies. ValGenesis, Inc. provides the first Enterprise application to manage the corporate validation lifecycle process. Through an industry peer review committee, the Parenteral Drug Association (PDA) recognized the ValGenesis solution with its very prestigious New Innovative Technology award. The ValGenesis Suite is designed to be fully compliant with U.S. FDA 21 CFR Part 11 as well as European Annex 11 requirements.

    Virje is an electronic quality management system (eQMS) for small and medium size medical device businesses.

    ZipQuality is a software enabled service that assists medical device companies in bringing new products to market. Our collaboration platform manages rapid design changes for agile teams while ensuring regulatory compliance.