Alternatives to RQM+
Compare RQM+ alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to RQM+ in 2026. Compare features, ratings, user reviews, pricing, and more from RQM+ competitors and alternatives in order to make an informed decision for your business.
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1
Qualio
Qualio
Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling -
2
Propel
Propel Software
Propel is a cloud-native platform that unifies PLM, QMS, and PIM in one connected system, giving manufacturers complete visibility and control across the entire product lifecycle. It provides a single source of truth for product data, streamlines change management, strengthens quality and compliance, and accelerates time-to-market by eliminating silos. With real-world AI use cases and enterprise-grade security, Propel helps organizations reduce errors and improve cross-functional alignment. Agentic AI accelerates change reviews, surfaces BOM and quality risks, enriches product information, and guides decisions—while role-based permissions and audit trails protect IP. From design through manufacturing and commercialization, Propel empowers companies to deliver innovative, high-quality products faster with greater confidence. Each module deploys independently with no required dependencies. -
3
RegDesk
RegDesk
RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market. Our capabilities are as follows: • AI Application Builder • Regulatory Intelligence • Change Assessment • Standards Management • Country-Specific Templates • Distributor Collaboration • AI Document Management • Tracking & Reporting • Alerts and Notification • Product Management • Claims Management • EUDAMED For more information, visit our website. -
4
Total Lean Management (TLM) Software
Lean & Mean Business Systems
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work OrdersStarting Price: $45/user/month -
5
Matrix Requirements
Matrix Requirements
For companies looking to accelerate development of their innovative medical device technologies, our Application Lifecycle Management and Quality Management Systems (eQMS) are easy-to-use, flexible, all-in-one software solutions designed to facilitate collaboration of employees on design control, and quality management to streamline medical device design. Innovate faster with a flexible item-based approach to documentation designed to control even the most complex SxMD (Software as/in a Medical Device) product design. Enhance quality management and ensure compliance with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams. Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more.Starting Price: $500 per month -
6
Intellect
Intellect
Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals. -
7
Greenlight Guru
Greenlight Guru
Greenlight Guru’s Medical Device Success Platform is the only all-in-one solution that helps you get your products to market faster, with less risk, and advance your success in-market. The platform helps companies manufacture safer products and get to market faster, simplifies regulatory compliance, and provides a single source of truth by connecting the management of all product development, regulatory, and quality processes from documentation and design controls to submission and ongoing compliance. Device makers across the globe are replacing reactive quality management tools and shifting their focus and efforts to ensure successful product launches and in-market success of innovative, life-changing devices. -
8
ZipQuality
Consensia
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. Pre-configured system(processes and tools); no need to alter your quality system. The integrated system easily handles rapid design iterations for product documentation. Experienced consultants guide your team at every step. Fully-featured, scalable software tools built on the proven, powerful ENOVIA platform. Our integrated system enables rapid design changes while keeping product documentation and data in sync and maintaining all the records in an audit-ready state. Product requirements, hardware requirements, software requirements. We understand complex, software-intensive medical devices. The ZipQuality system is based on a structured documentation framework that supports good systems engineering, efficient risk management, and clear traceability. -
9
SmartSolve eQMS
IQVIA
Eliminate manual, repetitive tasks so you can focus on delivering safer, more effective products – faster. IQVIA’s SmartSolve Postmarket Surveillance is your complete, SaaS approach for postmarket surveillance (PMS) and provides best practices for centrally managing all post market surveillance activities. Fusion is a SmartSolve and RIM Smart user event that provides an in-depth education into timely and relevant quality and regulatory topics with actionable insights and practical tools that can be applied within any Life Sciences organization. Fusion started as a live SmartSolve user conference and has evolved over the past couple of years to include virtual and live events for both SmartSolve and RIM Smart users. Simplify, automate and integrate your compliance response times, accuracy, predictive planning and efficiency with IQVIA SmartSolve™ Regulatory Connector. Connected Intelligence is our innovative, interconnected approach that helps to drive operational efficiencies.Starting Price: $542 one-time payment -
10
Opvia
Opvia
At Opvia, we empower R&D, manufacturing and quality management teams to build custom process operating systems that streamline their workflows and give them a competitive edge. We work with fast-growing startups and enterprises across a range of industries, including biotech, pharma, food and beverages, engineering and medical devices, to help them digitize their processes and bring innovative products to market faster. With our powerful tools and expert support, we give companies the freedom to create and deliver like never before. -
11
Scilife
Scilife
Revolutionize your Life Sciences processes. Drastically improve the control, efficiency, and quality of your processes and products. Ensure inspection readiness at all times through our fully compliant platform, pre-validated according to GAMP5. Maintain total control over processes and documents, customize workflows to perfection, and automate where possible. Enjoy uninterrupted workflows and full traceability through seamlessly connected and integrated modules. Our dedicated team is ready to answer your questions at any time. Only a first-class Scilife experience will do! Our Scilife platform streamlines automates and organizes every process in your industry space, whether you’re in Medical Devices, Pharma & Biotech, or ATMP. Click below to discover which Scilife modules support your unique industry lifecycle stages. Our software is equipped with all the advanced quality tools you would expect, and a bunch more that go above and beyond!Starting Price: $1000 -
12
InSilicoTrials
InSilicoTrials
InSilicoTrials.com is a web-based platform, which provides a user-friendly computational modeling and simulation environment where many integrated easy-to-use in silico tools are readily available. The platform targets primarily users from the medical devices and pharmaceutical sectors. The in silico tools available for medical devices enable computational testing in different biomedical areas like radiology, orthopedics and cardiovascular during product design, development and validation processes. For the pharmaceutical sector, the platform provides access to in silico tools developed at all stages of the drug discovery and development processes and for many different therapeutic areas. We have built the only cloud-platform based on the crowdscience concept that makes it easy to use validated models and cut your R&D costs now. A growing catalogue of models ready to be used, on a pay per use basis. -
13
Arena PLM
Arena by PTC
Arena PLM is a cloud-native and helps high-tech, medical device, life science, and aerospace and defense companies design, produce, and deliver innovative products quickly. By unifying all product information in a single, secure source of truth, product teams can collaborate anytime, anywhere. Arena streamlines new product development (NPD) and new product introduction (NPI) processes while ensuring regulatory compliance for FDA, ISO, ITAR, EAR, and environmental compliance.Starting Price: contact vendor -
14
MyBlueLabel
MyBlueLabel
Now you have the option of your own Quality Management Expert in the shape of an online platform. Templates ready to be integrated in your company to enable smooth processes. We offer complete Quality Management Systems and online solutions for ISO 13485 Medical Devices and ISO 9001 General Quality Management.Starting Price: $235 per month -
15
Orcanos ALM and QMS
Orcanos
Deliver products on time and on budget with Orcanos, an integrated software for ALM (Design Control) and quality management (QMS). An affordable cloud solution, Orcanos supports Requirements Management, Test Management, Document Control, Risk Management, and Quality Management procedures, on a single repository. Orcanos also features dashboards and real-time alerts, to help businesses keep track on their ongoing projects and gain real-time visibity on their progress. Orcanos e-DMS is an all-in-one document control software system that has been designed to allow end users to create, trace, search, archive and approve all documentation that is related to every stage of a medical device product launch. The e-DMS ensures that documents relating to the planning, design, development, manufacturing and service of a particular product can be quickly accessed, increasing the effectiveness of quality processes and reducing the time to market.Starting Price: $69.00/month/user -
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AmpleLogic Quality Management
AmpleLogic
AmpleLogic's Quality Management Software (eQMS) is intricately crafted to meet the rigorous requirements of heavily regulated industries. The ISO 9001 certified cloud-based Quality Management System (QMS) is ideal for Lifesciences, Food & Beverages (F&B), Cosmetics, Medical Devices, Gene Therapy, and analogous sectors. As businesses acknowledge the challenges associated with manual quality checks—prone to both laborious efforts and errors—they are increasingly adopting QMS software solutions. These systems play a pivotal role in enhancing audit quality through process automation, efficient data management, and seamless API integration. -
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Quality Connect
Montrium
Enterprise Quality Management Software in the cloud for the life sciences. In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays. Montrium has designed its Enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud. Perfect for pharmaceutical companies, contract manufacturing organizations, medical device companies. Built to achieve compliance with GMP and GCP requirements. -
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QAPI360
QAPI360
QAPI360 is a cloud-based, HIPAA-compliant Quality Assurance Performance Improvement (QAPI) software that centralizes, organizes and tracks all elements of a healthcare provider’s quality program so agencies can move beyond spreadsheets and disconnected processes to a systematic, data-driven approach; it includes structured QAPI plans, quality indicators, patient and staff incident tracking, infection control surveillance, medication error and adverse drug reaction logs, hand hygiene programs, performance improvement project templates, patient satisfaction surveys, and contracted provider performance tracking, with interactive dashboards, trending and analysis that help users visualize patterns, implement corrective actions, and monitor outcomes; it supports easy data entry, EMR integration or automated imports, built-in reporting and charts for compliance documentation and audits, and tools to streamline data collection, charting, and root-cause analysis.Starting Price: $249.99 per month -
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InstantGMP QMS
InstantGMP
Overall, a well-implemented QMS is essential for biotech companies to achieve regulatory compliance, maintain product quality and safety, manage risks effectively, drive operational efficiency, foster innovation, and build trust with customers. InstantGMP QMS is a complete, simple, and affordable quality management system software designed by quality and regulatory experts for biotech companies. It can also apply to small-to-midsize manufacturers in a variety of industries. This quality management software has guided workflows that reinforce adherence to government standards throughout the entire production process with a diverse array of innovative features and specialized modules. Helps maintain and improve the quality and safety of biotech products. Provides frameworks for identifying, assessing, and mitigating risks throughout the product lifecycle, reducing the likelihood of quality incidents and product recalls. -
20
Flinn
Flinn
Flinn is an AI-driven platform built to automate and streamline regulatory and quality-management processes within the medical-device (MedTech) industry. It enables manufacturers to integrate AI into repetitive and complex workflows such as post-market surveillance, literature evaluation, complaint-handling, and safety-database monitoring, reducing manual effort and ensuring compliance with standards like the EU Medical Device Regulation (MDR). It aggregates data across sources, applies machine-learning algorithms to detect patterns and risks, generates regulatory-compliant reports automatically, and supports rapid launch and operation of high-quality products at scale. As a result, organizations can achieve up to a tenfold acceleration in process efficiency while maintaining auditability, transparency, and traceability of their compliance workflows. -
21
ArborMetrix
ArborMetrix
At ArborMetrix, advancing healthcare through data science is our mission, and delivering high impact, intuitive technology and analytics is our passion. Our leading healthcare analytics solutions are proven to deliver targeted, clinically-deep insights that improve clinical outcomes, optimize financial performance, increase stakeholder value, and measure the real-world effectiveness of treatments and procedures, as well as medical device technologies and pharmaceuticals. Patient registries are useful across much of medicine, and post-market surveillance is one of their most valuable purposes. Here are the steps we take to help you create a trusted data resource. You need an efficient and secure way to collect large amounts of real-world data and prepare it for analysis. With the right technology, you can collect data from medical records, regulatory sources, patient-reported outcomes, and more for post-market surveillance activities. -
22
RAMS
Emergo by UL
Emergo by UL's Regulatory Affairs Management Suite (RAMS) is a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for medical device and in vitro diagnostic companies. Leveraging decades of regulatory compliance expertise, RAMS offers a suite of tools to navigate the complex and evolving landscape of global medical device regulations. Key features include product classification, which guides users through a series of questions to determine or verify device classification, and Smart Builder, a tool that provides step-by-step guidance and templated text to create accurate regulatory documentation, facilitating smoother device registration and faster market access. The Registration Tracker automates the tracking of global registrations and certifications, helping organizations avoid missed renewals and maintain compliance. -
23
Validfor
Validfor
Validfor is a secure, modular digital validation platform that centralizes the entire validation lifecycle on a single, paperless system. Designed specifically for regulated industries, Validfor enables efficient validation while ensuring full compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. The platform supports electronic records and advanced electronic signatures with full audit trails, role-based workflows (Author, Reviewer, Approver), and complete CSV compliance. All documents and records are securely managed in a centralized repository, capturing every change with full traceability to protect data integrity and Quality Assurance. Validfor offers integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, enabling seamless impact assessments, CAPA tracking, Computer Software Assurance (CSA), and audit-ready lifecycle management. -
24
Harrington Quality Management Software (HQMS)
Harrington Group International
HQMS' applications include Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. In business since 1991 – trustworthy source with SME Experts in Sales and Support will help with Business Case, Flexibility (on-premise or hosted, CapEx and Opex pricing models) with Support and Training & deployment planning that provides rapid learning curve with implementation guides. Secure deployment – including Single Sign On (SSO). Configuration and personalization features with customization if needed. HQMS is used cross several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.Starting Price: $500/month -
25
Virje
Virje
Virje complies with the requirements of 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. Overwhelmed by the thought of Part 11 software validation? Accessible from wherever you are, for whenever you work. Eliminate paper, reduce cost, and increase efficiency with automation and centralized collaboration. Perfect for small to medium-sized businesses. Built from the ground up specifically for medical device quality management. A system that is flexible enough to adjust to your workflows and processes, without having to compromise. Configurable change order approvals by employee role and by document type. Notifications to responsible personnel at every stage in the change process. Ability to designate material dispositions for individual documents. Easy access to released and historical versions of documents. Quick viewing of document change history. Tracking of where-used locations and distributed hard copies. Periodic document review notification. -
26
TraxQM
TraxQM
TraxQM is a risk-based Quality Management System (QMS) designed to help organizations manage regulatory compliance, streamline quality processes, and improve operational efficiency through a centralized, AI-enhanced platform. It enables companies to take a proactive approach to compliance by digitizing workflows and applying structured methodologies aligned with international standards such as ISO and GxP. It includes core modules for document management, risk analysis, CAPA (Corrective and Preventive Actions), change control, audits, and training, allowing teams to manage the full lifecycle of quality operations in one system. It supports data integrity through automated version control, audit trails, and compliant electronic signatures, ensuring traceability and adherence to regulatory requirements. TraxQM leverages AI to enhance decision-making by analyzing risks, suggesting targeted control measures, and recommending relevant KPIs based on organizational objectives.Starting Price: $403.97 per month -
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AssurX
AssurX
The AssurX platform is a versatile enterprise quality management system (EQMS) and regulatory compliance management platform. AssurX allows enterprises of any size or complexity to create a system that reliably communicates and coordinates quality and compliance information, documentation, and activities across the enterprise. AssurX allows regulated businesses to quickly identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. AssurX QMS software is highly configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure, and modify. -
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AmpleLogic APQR
AmpleLogic
Introducing AmpleLogic AI-based APQR software, a revolutionary solution that helps you generate accurate Product Quality Review (PQR) reports and CPV reports for audits and regulatory submissions as per the current Good Manufacturing Practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). With OCR data extraction and AI chatbot integration, AmpleLogic APQR solution streamlines document data extraction and quickens access to information, boosting audit readiness and operational efficiency. -
29
DHC VISION
DHC Business Solutions
We offer solutions for companies with a high demand for quality. Our software solutions inspire with a modern UX, useful functionality, high modularity, and consistent compliance. Integrated solutions for quality management and quality assurance. Focused on the digitization of controlled documents and QA processes. Solutions specifically designed to meet the needs of the financial industry for the written rules of procedure, management of policies, and the control of information security. The cloud-based, pre-validated solution to automate your validation processes and to digitally control and manage validation documents. Early set-up of a digital QMS with a dedicated solution for startups and young companies. Based on DHC VISION. It can be used out of the box with immediate compliance and no license costs. Together, we digitize quality management and quality assurance processes and ensure regulatory compliance. -
30
LifeSphere Medical Affairs
ArisGlobal
LifeSphere Medical Affairs is a cloud-based platform developed by ArisGlobal to enhance efficiency, compliance, and collaboration within medical affairs teams. It offers a unified workspace that seamlessly integrates medical information management with safety and quality systems, enabling end-to-end automation and real-time data sharing. The platform streamlines the intake and management of medical inquiries across multiple channels, automates the processing of product complaints and adverse events, and ensures consistent global compliance with evolving regulatory requirements. Its advanced analytics and reporting tools provide actionable insights, facilitating data-driven decision-making and improved patient outcomes. LifeSphere Medical Affairs is designed to be scalable and configurable, catering to the unique needs of organizations of all sizes. -
31
Ennov Doc
Ennov
Unified Access to All Documents - Consolidates documents & processes in a unified document repository that can be used for Quality, Regulatory, R&D and more. - Metadata-based document model to adapt to your company’s organizational needs. - Configurable without any IT skills. - Scalable & secure: manage large volumes of documents. Improved Productivity and Efficiency - Intuitive user interface - Efficient search capabilities - User-centric design and connectivity to Microsoft Office 365 and Google Drive - PDF viewer to allow instant access to documents without MS Office or Acrobat - Versioning - Complete document cycle management Supports wide EDM needs - Quality, regulatory, cR&D, legal, commercial - CFR21 part 11 compliant - Document archival included - Seamless integration with Ennov Process (BPMS) & Dossier (eCTD publishing) - Advanced live reporting and dashboarding - Configurable without IT skills (including dashboards) - Suitable for regulated industries -
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CASQ-it
BÖHME & WEIHS
Defect-free business processes lead to defect-free products. And that is exactly why CASQ-it is designed to encompass all the steps in your quality assurance and quality management processes – starting with the development process, continuing through the material process – up to and including your support processes. The advantage of CASQ-it lies right here in this process-oriented mode of operation – functionality that enables your CAQ system to adapt flexibly to your processes – and not vice versa. CASQ-it supports your quality assurance processes on their journey into the future: Quality and reliability increase customer satisfaction whilst reducing the cost of quality. Each separate CASQ-it module functions independently – enabling you to optimize individual processes and workflows within your company right from day one. Our modules can be flexibly combined – or used to create a comprehensive quality assurance system. -
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Essenvia
Essenvia
Essenvia drives business value and brings cross-functional efficiency gains to all teams and departments. Centralized repository for all regulatory information, enabling collaborative authoring and reporting while eliminating technical holds, RTAs, and RFIs. Empowerment of regulatory affairs department to accelerate product launches and eliminate revenue loss due to submission delays and missed renewals. Helicopter view of the total regulatory lifecycle. Executive dashboards, metrics, and proactive alerts for global registrations, submissions, and change assessment. Essenvia is a RIM Platform that enables you to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Consolidate your regulatory activities into one centralized platform and bring your devices to market faster. Central repository for all registration docs linked to product master data. Manage product registration lifecycle by country. -
34
Sorcero
Sorcero
Sorcero is an AI-powered platform designed to transform complex medical data into actionable insights for the life sciences industry. With its suite of products, including Medical Insights Management, Intelligent Publication Monitoring, Plain Language Summaries, and Intelligent Systematic Literature Review, Sorcero unifies and analyzes unstructured and structured data from a variety of sources. By using AI to analyze medical themes, notes, and research, Sorcero delivers high-quality, easy-to-understand answers to complex medical questions, helping teams in Medical Affairs, Pharmacovigilance, and Regulatory Affairs drive more informed decisions. The platform supports rapid literature monitoring, content generation, and evidence-based decision-making, ultimately boosting patient outcomes and enhancing operational efficiency. -
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BIOVIA
Dassault Systèmes
BIOVIA solutions create an unmatched scientific management environment that can help science-based organizations create and connect biological, chemical and material innovations to improve the way we live. The industry-leading BIOVIA portfolio is focused on integrating the diversity of science, experimental processes and information requirements end-to-end across research, development, QA/QC and manufacturing. Capabilities over the areas of Scientific Informatics, Molecular Modeling/Simulation, Data Science, Laboratory Informatics, Formulation Design, BioPharma Quality & Compliance and Manufacturing Analytics. BIOVIA is committed to enhancing and speeding innovation, increasing productivity, improving quality and compliance, reducing costs and accelerating product development for customers in multiple industries. Manage and connect scientific innovation processes and information across the product lifecycle. -
36
LICENSALE
Arazy Group
All-in-one global regulatory affairs system, complete with registration management software and worldwide assistance from regulatory experts. The registration system you need to initiate, renew, amend or transfer your medical device or IVD market access approval. LICENSALE®‘s intuitive user interface with real-time data includes complete project management, infographic analytics, an effective collaboration platform, future market access planning and advanced reporting. It puts you in control of your global medtech registration activities. Arazy Group “in-country” regulatory experts review your compliance documents, assisting in the preparation and submission of your applications. They work with authorities until you obtain your desired marketing approvals. LICENSALE® includes submission and compliance requirements specific for your product in over 140 countries as well as regulatory experts to assist with each of these markets. -
37
QUMAS EQMS
Dassault Systemes
To bring new products to market as quickly as possible in compliance with global regulations, organizations need to standardize and automate their business processes that manage the collection, tracking and analysis of information and the resolution of related issues. QUMAS EQMS (formerly ProcessCompliance) is a cloud-based solution for Enterprise Quality and Process Management that delivers comprehensive integrated regulatory, quality and compliance management capabilities in a validated QMS environment. QUMAS’s data-centric approach allows you to flexibly manage quality content and to access and re-use all quality data, providing comprehensive visibility into Quality. QUMAS’s interactive quality dashboards provide QMS overview across business areas and quality initiatives. Reports are available for export, email and scheduling. QUMAS allows QMS departments to exchange information securely, efficiently and compliantly in the cloud. -
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Samarind RMS
Instem
Samarind RMS provides a smarter way to manage your medical product information. Using Samarind RMS, you only need to enter data once and can reuse it as many times as required. For example an ‘INN’ can be entered once and reused for all related IMA submissions, renewals, variations, PSURs and XEVMPD submissions. This concept applies to all key data held within the system and is proven to streamline workflows and help to increase data quality. Our pragmatic approach to systems design and implementation means that our customers can manage their licenses smoothly and efficiently, safe in the knowledge that our single-place-of-truth™ approach for regulatory affairs professionals delivers a complete end-to-end system. An electronic document management system (EDMS) with version control, template creation and the ability to link to external document management systems such as Documentum™ or SharePoint™. -
39
QEdge
Sarjen Systems Pvt Ltd
Sarjen’s Quality Management Software brings meaningful digital transformation to how quality is managed across regulated manufacturing environments. More than just a system to store compliance records, it uses AI to turn quality data into actionable insights. AI analyzes trends, spots early signals of deviation, and predicts potential quality risks before they impact products or processes. Automated alerts and intelligent recommendations help teams act faster, reduce manual errors, and strengthen decision-making with context-aware guidance. With machine learning, the system continuously learns from data patterns and improves accuracy over time. By combining robust quality workflows with AI-driven intelligence, the solution enhances product consistency, accelerates investigation cycles, and ensures stronger compliance. It makes quality management smarter, more proactive, and easier for your teams to adopt and trust. -
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ClinChoice
ClinChoice
ClinChoice manages global regulatory information with expert technology prowess, a deep understanding of global and local regulations, and the best data management practices. ClinChoice applies its expertise in regulatory affairs and technology to help organizations manage their regulatory data. Our consultants provide general data maintenance support in regulatory information management system (RIMS) software to deliver solutions that will ensure application submission, approval, renewals on time, improve operational process efficiency and tracking. We provide the required support in the management and control of the drug registration process, which helps the drug and medical device manufacturing companies to have visibility and tracking of all regulatory information. With our help, organizations can develop short- and long-term strategies to meet submission timelines with minimal impact on day-to-day operations. -
41
MedAffairs AI
Accreditation Council for Medical Affairs (ACMA)
MedAffairs AI is a cloud-based, AI-enabled machine learning tool specifically designed to enhance the Medical Affairs function within the pharmaceutical industry. Trained on the largest compendium of medical affairs data, it offers rapid and accurate responses to user queries, significantly reducing the time spent searching through shared drives and folders. The platform allows for the seamless integration of internal documents, including clinical studies, standard operating procedures, and articles, enabling users to effortlessly retrieve answers by querying their internally uploaded resources. Each response is accompanied by the corresponding source document for easy reference. MedAffairs AI supports both internal and external data searches, providing comprehensive insights into medical information, regulatory affairs, compliance, key opinion leader engagement, medical strategy, and planning. -
42
Nova-QMS
Novatek International
Maintaining consistent product quality and quality processes can be challenging in today’s pharmaceutical manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices. -
43
TrackWise
Honeywell International
Honeywell's TrackWise Digital® is a cloud-based Quality Management System (QMS) designed to help organizations efficiently manage quality and compliance processes. Leveraging nearly three decades of industry experience, it offers integrated modules that support various quality management aspects, including document control, training management, and corrective and preventive actions (CAPA). The platform incorporates advanced digital technologies such as artificial intelligence and machine learning to provide actionable, real-time insights, enabling proactive quality management. Its flexible, modular architecture allows for seamless integration with existing enterprise systems, facilitating rapid deployment and scalability. By streamlining quality processes and ensuring compliance with industry standards, TrackWise Digital® empowers organizations to bring products to market faster while minimizing risk.Starting Price: $200 per month -
44
ACMA Engage
Accreditation Council for Medical Affairs (ACMA)
ACMA Engage is a specialized Customer Relationship Management (CRM) platform developed by the Accreditation Council for Medical Affairs (ACMA) to enhance the efficiency and effectiveness of Medical Affairs and Medical Science Liaison (MSL) teams. This web-based system offers convenient access across all devices, enabling professionals to manage Key Opinion Leader (KOL) interactions and medical affairs activities seamlessly. Designed with input from industry experts and feedback from thousands of BCMAS-certified professionals, ACMA Engage provides a fully searchable, relational database of information about healthcare opinion leaders associated with the treatment of diseases or the use of pharmaceutical/biopharmaceutical products or devices. Key features include face-to-face meeting management with thought leaders, Phase IV trials oversight, a 360-degree view of compliant interactions, and education alignment with outcomes. -
45
ANCORA
Amedea Pharma
Amedea Pharma offers a suite of innovative solutions designed to elevate the performance and quality of Medical Affairs in the life sciences sector. Their flagship product, the ANCORA Decision Assistant Platform, is a SaaS software that employs a unique DeepMetrics method, integrating sports and data science to enhance business operations. This platform has been beta-tested in two major drug launches, demonstrating efficiency increases of up to 141%, productivity boosts of up to 416%, and a 25% reduction in employee costs. Additionally, Amedea Pharma provides a generative AI-based medical insights platform utilizing large language models to facilitate natural conversational searches, meeting summarizations, and actionable recommendations. Their professional services encompass the development of a comprehensive medical affairs metrics playbook, coordination of internal innovation events modeled after their annual Medical Affairs Innovation Olympics. -
46
Close-Up CRM
Close-Up International
Close-Up International is a leading provider of market data and technology solutions tailored for the pharmaceutical and life sciences industry. With over 55 years of experience, Close-Up supports more than 650 clients across 50 countries by delivering high-quality, certified data and innovative analytic tools. Their solutions help companies assess market potential, target healthcare professionals, and optimize product launches. The platform integrates market, prescription, and sales data with CRM capabilities for a comprehensive view of market dynamics. Close-Up’s offerings are designed to improve decision-making and strengthen relationships between pharmaceutical companies and healthcare providers. They emphasize data security, holding ISO 9001 and 27001 certifications. -
47
Quality Link
Quality Mapping Solutions
Inspired by people and technology, Quality Link 7 builds on our experience and proven platform for helping organizations automate processes, save money, and achieve regulatory compliance with an easy-to-use business operating solution. Quality Link delivers improved efficiency while eliminating manual paperwork with our document management. Every document you create will be stored and managed from within this module. You can print “uncontrolled” copies of your documentation from within this module, as well as perform many other document-related activities. With the enhanced organization, you’ll see clerical tasks by quality personnel reduced by up to 90 percent. Our software effortlessly converts existing documentation from your previous management system, and there’s no learning curve. But you won’t miss your favorite applications, as they can be easily integrated. With Quality Link, you can say good-bye to manual document maintenance, which requires constant monitoring. -
48
DataMetrics
DATAMYTE
No matter what product you manufacture, DataMetrics can provide your operators, engineers, quality team, and managers with the detailed, real-time SPC data, analytics and reporting, they need to assess current processes and take a proactive approach to maintain or improve product quality, meet production goals, reduce costs arounds scrap and rework, comply with OEM or industry standards. A genius interface to your entire manufacturing floor to support universal data collection across manual, semi-automated, automated and portable data acquisition; giving you the ability to capture ALL of your quality data into one centralized repository or database and report on this data. Eliminate data silos while consolidating data from hundreds of gages, sensors, CMM, PLC; essentially any type of open interface. Compliant with OPC-UA, DataMetrics is a solution backed by stringent access control and advanced security. -
49
3D Organon
3D Organon
3D Organon is a leading medical and healthcare education platform designed for teaching and learning medical concepts across virtual reality, desktop, tablet, and mobile devices. Its prime solution, 3D Organon XR, is the world's first fully-featured VR software for comprehensive medical education, offering an unparalleled experience in exploring and understanding the complexities of the human body and medical practices. The platform features life-like anatomy models within immersive environments and an extensive knowledge base of anatomical definitions translated into 16 languages, transforming the challenging subject of medical anatomy into concrete knowledge readily applied to clinical practice worldwide. 3D Organon includes detailed anatomy exploration, XR medical imaging, ultrasound simulation, comprehensive quizzes, and the innovative Medverse, providing users with a comprehensive suite of tools for learning and practicing medical knowledge. -
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Cruxi
Cruxi
Cruxi is a vertical AI platform built specifically for medical device regulatory teams. It ingests FDA regulations, guidance, product codes, standards, MAUDE events, recalls, and prior 510(k) data to power agentic workflows for 510(k), De Novo, and eSTAR. Users can run rapid device classification, compare predicates, plan evidence, and generate fully cited, eSTAR-aligned content for each subsection of the submission. Cruxi offers both full-submission workflows and focused micro-services (e.g., classification, predicate analysis, specific section drafting), making it ideal for early-stage startups, in-house regulatory teams, and consultants who want to deliver high-quality submissions with less manual work and fewer surprises from FDA.Starting Price: Credit-based system
