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 Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality

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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 Identif

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

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

    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

    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.

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

    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.

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

    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.

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

    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.

    Ennov Doc is part of Ennov's ECM platform for regulated industries, especially the Life Sciences Sector. Our solution is recognized by Gartner as a relevant actor in the Life Sciences sector (mentioned in Gartner's Hype Cycle for Life Sciences Reports as a Regulated SaaS EDMS, as well as for eTMF and QMS) , and suitable for large as well as small organizations. It comprises in the same interface and completely integrated : Document management (EDMS), Business process management (BPMS), Dossier

    Ennov Process allows you to automate your Quality processes and enforce the activities, participants and traceability required by your SOPs using our visual form builder and graphical workflow modeling utilities. Ad hoc processes or those that remain stalled for months are a thing of the past.

    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.

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

    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.

    By integrating your Quality, Health, Safety & Environmental Management systems in the Cloud and on a Mobile App

    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.

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