QMS Software for Medical Devices & IVD
QMS Software Solution as You Need It
We help medical device and IVD companies unlock the full potential of QMS digital transformation. Our quality management solutions combine platforms like Microsoft SharePoint, M365, Confluence, and Jira.
We build customized QMS software tailored to your processes, always validated, audit-ready, and compliant with MedTech regulations.
The best QMS is not one that makes you adapt, it’s the one that adapts to you.
- Microsoft & SharePoint-Based QMS
- Jira & Confluence-Based QMS
- Custom QMS & Integrations
- AI-Enhanced QMS Solutions
We believe QMS Software shouldn't force you to change the way you work. Instead, it should adapt to you, grow with you, and fit into your existing environment.
We build:
- QMS Solutions customized around your processes
- Scalable QMS Software that evolves as your organization changes
- Integrated QMS connected with the software you use
Smarter QMS Software
QMS Solution Beyond Ready-Made Packages
Most off-the-shelf QMS Software tries to cover everything with a rigid feature view. This often creates inefficiencies, unnecessary complexity, or the need to change how people in your organization work.
At QMLogic, our approach is different.
- We integrate with your existing tools instead of replacing them, and build additional functionalities just where it is needed
- We connect departments and systems into one functioning ecosystem
- We reduce cost and complexity while improving clarity, communication, and efficiency
QMS Software Solutions Tailored to Your Technology Environment
We build QMS Software solutions that adapt to your organization, not the other way around.
Our strength lies in flexibility: whether your company operates on Atlassian, Microsoft, or other software solutions in a hybrid environment, we design a Customizable QMS Environment that integrates seamlessly with your business.
What You Gain With Our QMS Software
Optimized Efficiency
Automate repetitive quality tasks to save time and reduce manual effort.
Fewer Errors, More Accuracy
Minimize risk with automated workflows and consistent, validated data.
Simplified Audits & Full Traceability
Real-time dashboards and audit trails for effortless compliance.
Reduced Costs & Complexity
Optimize workflows, minimize redundancy, and improve team productivity.
Centralized Insights
Bring all your quality data together for better visibility and faster decision-making.
Our Core eQMS Technology Foundations & Software Tools
We build compliant, scalable and connected Quality Management Systems (eQMS), adapted to your company’s size, needs, and existing setup. Instead of forcing a single technology, we build on what you already use or introduce new tools where they bring real value.
Our implementations are designed around compliance with core standards and regulations, such as ISO 13485 or 21 CFR 820, and beyond. We ensure your QMS is digitalized, audit-ready, and future-proof. By leveraging proven platforms and our regulatory expertise, we deliver compliant eQMS solutions faster, with minimal disruption to your ongoing operations.
Your tools, your processes, our expertise, transformed into a digital QMS.
QMS Built on Your Infrastructure
We design QMS environments built on Microsoft technologies, using SharePoint, Power Platform (Power Apps, Power Automate, and Power BI). We deliver a seamless, secure, and compliant QMS automation system, designed around your exact needs.
Full Ownership & No Vendor Lock-In
No licensing traps, hidden dependencies, or external vendor lock-ins, the system is fully yours to manage, adapt, and evolve.
Data Stays Inside Your Company
We don't store or access any data once the system is under your control. You can leave anytime, without losing control of your records and manage your own administration.
MedTech Compliance Built-In
We design with ISO 13485, FDA 21 CFR Part 820, Part 11, and MDR in mind, ensuring every workflow and form meets regulatory requirements from the start.
Microsoft 365 Integration
Our solutions are natively built on PowerApps, SharePoint, and Power Automate, integrating seamlessly with your existing Microsoft environment for a unified QMS ecosystem.
Modular & Scalable
Start small with essential workflows and extend functionality step by step. No need to build everything at once, your QMS can grow with you.
Using Confluence and JIRA, you can build a powerful, collaborative, and compliant QMS system. Thanks to their usability and ease of adoption, these tools are loved by teams worldwide and have become standard in many organizations. They make collaboration simple, support agile frameworks like Kanban and Scrum, and help small and mid-sized companies achieve strong QMS foundations. With the right modules for review and approval processes, you can create a robust, compliant solution aligned with required norms.
Turn Your Favourite Atlassian Tools Into a Compliant Solution
Do not think Confluence and JIRA cannot meet regulatory norms. With the right setup, you can keep using your preferred tools while staying compliant with ISO 13485, FDA 21 CFR Part 820, Part 11, and related standards.
Stay With The Software You Like
No need to switch to rigid, old-school regulatory systems. If your teams already love Confluence and JIRA, we adapt your processes and configure these platforms so you can stay compliant while working in the environment you know best.
Extend Capabilities With Proven Add-Ons
Enhance Confluence and JIRA with trusted marketplace apps like Comala Document Management, K15t Scroll Versions, or eSignatures for Confluence. Where needed, we guide you in selecting and integrating the right modules.
Build Custom Solutions When Needed
When standard apps are not enough, we develop tailored solutions. From advanced ScriptRunner automation to fully custom-built apps or API-based integrations, we unlock powerful capabilities to make your QMS in Confluence and JIRA both compliant and highly efficient.
Custom QMS Solutions
Beyond Atlassian and Microsoft environments, we create custom QMS software and integrations tailored to your exact needs. This can mean:
- Connecting Atlassian and Microsoft worlds where necessary
- Building new software components that fill functionality gaps
- Developing standalone QMS modules for specific business needs
- Extending interoperability with tools such as SAP, Polarion, IBM DOORS
When standard tools can’t meet your needs, we design custom eQMS software from the ground up. Our solutions are audit-ready by design, aligned with ISO 13485, FDA 21 CFR, and EU MDR, and tailored to your product lifecycle, regulatory framework, and internal SOPs.
Enhancing Microsoft Solutions
We extend SharePoint and Power Platform with advanced capabilities using:
- SPFx, Graph API & Custom Connectors for deeper functionality
- New apps, dashboards, and integrations built on Microsoft 365
- Expanded automation and reporting without vendor lock-in
Different departments thrive with different tools: developers rely on JIRA, process owners prefer Confluence, documentation may end up in SAP or SmartSolve, and requirements engineering often lives in Polarion or IBM DOORS.
Forcing everyone into a single system does not work. The real solution is integration, connecting tools so each team can continue working with what fits them best, while processes and data flow seamlessly across the organization.
Intelligent Connections Between Documentation and Archiving
Confluence makes editing and collaboration on documents effortless. Yet organizations often require archiving, regulatory workflows, or approval processes supported by systems like SAP or SmartSolve. By linking these environments, teams can keep the simplicity of Confluence while compliance and storage requirements are satisfied elsewhere.
Align Requirements Engineering With Agile Development
Robust tools like Polarion or IBM DOORS are ideal for structured requirements engineering. At the same time, agile teams need JIRA to manage stories, epics, and sprints. Integration bridges these worlds, ensuring structured requirements flow into agile execution without forcing teams to abandon their preferred methods.
From Confluence to Training Systems Automatically
Content is easily created and reviewed in Confluence, but training delivery requires different handling. Automating exports of approved content into dedicated training systems ensures knowledge transfer is controlled, traceable, and always up to date—without extra manual steps.
Business Intelligence That Works Across Teams
Teams may use JIRA for development or customer support, while management requires aggregated reporting in Power BI. By connecting these systems, business departments gain the insights they need without disrupting teams that prefer to remain in JIRA or Confluence. Everyone works in their own environment, while data connects where it matters.
Eliminate Copy-Paste and Miscommunication
Integration avoids tedious duplication and reduces friction between teams. Each department uses the tool they know best, while seamless data flows ensure accuracy, compliance, and efficiency. Work moves faster when tools talk to each other, and people can focus on delivering results instead of reconciling systems.
Fully Custom Software Development
For organizations needing complete flexibility, we build standalone or cloud-based solutions:
- Technologies: React, Java, .NET, Next.js, Azure and more
- Full-stack development for any process automation
- Automate any QMS or business process without platform limits
- Designed for ISO 13485, FDA 21 CFR, and EU MDR compliance from the start
AI-Based QMS Features
AI is the intelligence layer that connects platforms, processes, and people.
At QMLogic, we embed AI into QMS environments, transforming simple automation into intelligence. Our AI-driven solutions extend beyond simple workflows, bringing smart assistance, predictive analytics, and self-optimizing processes to your quality ecosystem.
What AI Bring to Your QMS
- Automated QMS & TechDoc content creation for faster, consistent documentation
- Document consistency & template compliance with instant AI-based checks
- Predictive project tracking & bottleneck detection across your quality processes
- AI-powered knowledge assistants for quick access to product and process data
AI enables your QMS to think ahead — detecting risks, identifying trends, and ensuring traceable, audit-ready documentation.
The result: fewer errors, stronger compliance, and faster, smarter decisions.
At QMLogic, we do not offer just predefined or limited AI features. In the same way we design customizable QMS Software Solutions, we also create custom AI-augmented functionalities for specific needs of each organization.
Practical AI that strengthens compliance and accelerates performance.
AI for Multiple Quality Management System Areas
Control of documents and records
Automatically checking consistency between procedures, templates, and records
Design control processes
Supporting requirement engineering, design specification, validation, and verification activities
Product lifecycle and risk management
Identifying gaps, trends, and risk correlations
Cybersecurity processes
Improving incident monitoring and risk prioritization
Audits, data analysis, and management reviews
Assisting with data preparation, audit traceability, and evidence collection
AI transforms QMS from automation to intelligence, with predictive analytics, risk detection, and smart documentation support. The result: fewer errors, stronger compliance, and faster decisions.
QMS Software Tools
Real-World Use Cases of Our Custom QMS Solution
We don’t just talk about automation, we deliver it. Our solutions are born from real-world challenges we’ve solved for MedTech companies, replacing slow, manual processes with fast, compliant, and fully digital systems.
DocuRoad
Product Lifecycle Management Tool
A custom-built solution that streamlines documentation and project workflows across departments.
- Centralized control over documents, versions, and change management
- Manage project releases and collaboration across multiple teams
- Track document progress and criticality for project managers
- Built-in roles and permissions for secure workflows
- Confluence integration for easy export and consistency checks across document versions
Computer System Validation App
An app designed to fully automate software tool validation.
- SharePoint as a secure storage backbone
- Power Apps UI for simple, guided navigation
- Power Automate for alerts, notifications, and automated document exports
- PDF export for validation records
- Built-in statistics and dashboards to track validation progress in real time
- Shows how any process can be quickly digitized and automated, while keeping data inside the company
Application of AI in QMS
AI in QMS isn't just about automation, it's about intelligence, foresight, and compliance at scale. By embedding AI into our solutions, we enable MedTech companies to move from manual oversight to predictive, self-checking systems.
Smarter Decisions, Backed by Real-Time Insights
Our interactive, AI-augmented dashboards provide valuable insights across your organization, enabling you to make the right decisions quickly and confidently, without tedious manual data collection.
With just a few clicks, you gain access to:
- Real-time analytical overviews
- Automated performance tracking
- Intelligent summaries that support management reviews and continuous improvement
Empower your quality experts with AI, make your QMS smarter and responsive!
Examples of AI-Driven Use Cases in QMS
QMS & Product Knowledge Chatbots
Provide instant answers and guidance to your teams, directly from your validated QMS data.
Automated Document Generation
Speed up compliance reporting, audits, and technical documentation with AI-assisted drafting.
Audits & Management Reviews
Generate real-time summaries, findings, and corrective action insights.
Requirements Alignment & Quality Assurance
Cross-check design controls, CAPAs, and requirements for consistency and compliance.
Predictive Project Tracking & Bottleneck Detection
Spot risks before they turn into delays or non-compliance issues.
Document Consistency & Template Compliance
Ensure every record meets QMS and regulatory standards automatically.
With AI integrated into your QMS, quality management becomes proactive — a system that learns, predicts, and supports compliance every day.
QMS Software Compliant with ISO 13485 and 21 CFR 820
Our team have guided organizations through multiple certifications and audits, ensuring solutions meet global standards. Compliance always remains in focus. That’s why our solutions are designed to meet regulatory requirements from the ground up.
ISO 13485
for medical device quality management
ISO 80002-2
Computer System Validation
ISO 27001
for data protection and information security
ISO 42001
Artificial intelligence – Management system
21 CFR 820 (QMSR)
for FDA-regulated environments
Extending Compliance Beyond the Core QMS
In medical device development and manufacturing, compliance extends beyond ISO 13485 and 21 CFR 820. That’s why our eQMS Solutions also cover broader regulatory and lifecycle requirements essential for maintaining compliance throughout the entire medical device life cycle.
21 CFR 820 (QMSR)
for FDA-regulated environments
- Medical Device Reporting (MDR) – 21 CFR 803
- Medical Device Tracking Requirements – 21 CFR 821
- Postmarket Surveillance – 21 CFR 822
EU MDR
Medical Device Regulation 2017/745
- Post-Market Surveillance
- Vigilance System
- Post-Market Clinical Follow-Up (PMCF)
- Periodic Safety Update Reports (PSUR)
Built-in compliance by design. Aligning innovation with assurance, seamlessly
These functions ensure that your QMS not only manages internal processes but also supports regulatory submissions, incident reporting, field actions, and market surveillance activities — all within a unified, secure environment.
Your Right Partner in QMS Software Implementation
Building eQMS that Works for You and Auditors
At QMLogic, we don’t just talk about QMS digitalization; we have delivered it successfully across industries and technologies. We have designed and implemented Quality Management Systems from the ground up several times.
Experience Across Platforms and Technologies
We have created digital Quality Management Systems on different technological backbones:
- Atlassian Suite (Confluence & Jira) for agile QMS workflows
- Microsoft tools (SharePoint, Power Apps, Power Automate, Power BI) for scalable, enterprise-wide QMS solutions
- Custom-built software tailored for QMS documentation, design controls, risk management, or complete business operations
Beyond standalone systems, we have enabled interoperability with tools such as:
- SAP ERP systems
- Requirements engineering tools like Polarion
- Document management platforms like SmartSolve
Compliance You Can Trust
Our solutions have been audited multiple times by notified bodies and external auditors and confirmed to be:
- Fully compliant with ISO 13485, 21 CFR 820, IEC 62304, and ISO 14971
- Designed to ensure compliance with cybersecurity and data privacy requirements defined by ISO 27001 and IEC 81001-5-1
- Ready for regulatory scrutiny, certification audits, and global compliance needs
We go beyond audit readiness, delivering systems that align compliance with business effectiveness, cost efficiency, and sustainable growth.
Testimonials | Expertise in QMS Digitalization
Vaclav did support our journey to become ISO 13485 certified with relentless work put into great processes, great communication and detailed and to the point conversations with the teams, individual members - but also our external auditors. He was of great support to move our QMS to the next level. He was the key person behind the move away from paper / scan based documents towards a digital setup.If you are in need for a structured person with great communication skills, a good understanding of the regulatory environment, I can only recommend to reach out to Vaclav. Lucky you if he's not booked ;-) Besides all the success he's an enjoyable and humble character. Great experience to having worked with him.
Vaclav and I worked together on risk management activities of medical device development projects. His ability to quickly grasp the challenges and to accomplish a task/project is remarkable. Additionally, his ability to propose and develop software solutions to improve projects’ efficiency is commendable. I find Vaclav to be flexible, dependable, and quality centric. Hence, I really enjoyed working with Vaclav and looking forward to associate with him again.
Our Vision of a Modern eQMS for Operational Excellence
We at QMLogic design QMS Software with one principle in mind: no two organizations are the same. Every company has its own way of working, its own companion software. It operates within various regulatory frameworks and medical device areas, including mechanical, electronic, hardware, software, and cloud-based software. And every company treats design and development, suppliers, customers, and many more differently.
That’s why there cannot be a single ready-made QMS that fits everyone. In reality, so-called “catch-all” solutions are closer to science fiction or brave marketing slogans than practical reality.
Instead, we focus on Customizable QMS Software Solutions that adapt to your organization. We build systems that are interoperable with your existing tools, reflect your workflows, and grow as your company evolves.
With this philosophy, let’s look at the key areas of the Quality Management System, as described in ISO 13485 and 21 CFR 820, and how we envision them in a modern QMS Software environment.
Your QMS should not be where documents go to die. It should be where processes come alive.
QMS Software as a Living Environment
Many organizations start with control of documents and records as the foundation of their Quality Management System. While this is an essential cornerstone, a QMS cannot be reduced to simple document storage. Without automation, integration, and real-time accessibility, a QMS becomes nothing more than an archival tool, failing to add real value to the organization.
At QMLogic, we build Customizable QMS Software Solutions that reflect real workflows, automate daily tasks, and create evidence of functioning processes. We believe in systems that live, evolve, and drive efficiency, while staying compliant with applicable standards and regulations.
Every effective QMS begins with document and record control. This is the starting point for compliance audits and one of the most critical areas of regulatory scrutiny.
But in our view, document control is more than archiving. The eQMS must provide:
- An effective way for reviewing and approving documents throughout the organization
- Automated notifications about updates to processes, templates, and work instructions
- Collaborative content creation, not just static storage
A QMS is only effective if people understand and apply its content. That’s why training systems are tightly connected to document management.
Our approach ensures that:
- Documents are distributed to the right audience automatically
- Training procedures verify that the content has been read and understood
- Evidence of training is created and linked back to document control
This creates a living link between compliance documentation and employee competence.
Records are more than files; they are the footprints of daily business operations. In a modern QMS Software environment, records should be created naturally as employees carry out their work, not as an extra administrative burden.
We support organizations in building custom QMS solutions around design and development activities. Depending on your needs, this can be:
- A fully custom-built Design Control solution, developed to cover your specific processes
- An integration with third-party tools such as Jira, Polarion, or IBM DOORS, extending their capabilities with compliance, automation, and traceability
Our approach ensures that while your team continues working in its familiar environment, required records are created automatically, enabling:
- Full traceability and compliance with regulatory standards
- Improved cooperation and communication between departments
- Automation of tedious tasks and reduction of manual work
When production and servicing data flow naturally into the QMS, compliance and efficiency stop being separate goals, they become one.
Production, installation, and servicing are integral parts of any Quality Management System, yet they are often disconnected from traditional QMS software. The reason is simple: these activities are dynamic, asynchronous, and highly customized for every client.
Servicing a medical software product is vastly different from maintaining a physical or electronic device. Expecting one rigid system to manage all these variations only leads to inefficiencies, parallel tools, and fragmented processes.
Our approach is to design solutions that:
- Capture records directly while activities are performed, not as a separate afterthought
- Allow different types of servicing and production processes to coexist in one environment
- Provide transparency and clarity so that all stakeholders see the same information in real time
By connecting these operational processes into the QMS, organizations gain a system that reflects reality—not just a static archive.
Purchasing is another area tightly connected with the control of records, an important part of QMS. Every organization has its own purchasing process, usually based on internal approvals, whether derived from the role requesting the purchase, the department making the request, or the type of item being purchased.
What often makes purchasing inefficient is that these processes are scattered, handled manually, or disconnected from other systems. This not only creates delays but also increases the risk of unintended errors and unnecessary costs.
Our approach is to build custom digital workflows for purchasing that:
- Streamline approval chains and ensure requests reach the right people quickly
- Synchronize purchasing with other organizational processes (such as production, project planning, or supplier management)
- Provide transparency across the organization, so every request and decision is traceable and clear
- Reduce manual work and facilitate collaboration between departments
The goal is not just to digitize approvals but to create a purchasing process that naturally fits into your broader Quality Management System environment. When purchasing is managed in a connected way, it becomes faster, more efficient, and far less prone to error, while also supporting better financial control and organizational agility.
An efficient purchasing system is more than approvals—it is the nervous system that keeps the whole organization supplied, connected, and moving forward.
One of the most demanding aspects of a Quality Management System is ensuring that processes are continuously measured, analyzed, and improved. While the standards make these requirements clear, in practice, this is where many organizations struggle the most.
The challenge lies not only in defining what should be measured or analyzed, but also in gathering and interpreting the right data. Traditional QMS software often fails in this regard because it provides records without offering the necessary connectivity or context. As a result, measurement and analysis become:
- Time-consuming
- Error-prone
- Nearly impossible in complex organizations
Our approach focuses on creating a connected environment where data from across the organization is available in one place. This makes it possible to:
- Collect and analyze customer feedback, complaints, and supplier evaluations
- Monitor and track nonconformities and internal process performance
- Link training results, production data, and service activities into a broader analysis framework
- Provide holistic, real-time insights instead of static reports
Without interoperability between systems, true analysis remains out of reach. With it, organizations can finally transform raw data into clear insights and actionable improvements.
Data Analysis is not about gathering data, it's about connecting the right data and making it meaningful.
A modern Quality Management System does not exist in isolation. Many parallel departments work in conjunction with the QMS, even if they are not formally considered part of the QMS.
For example:
- Legal departments manage contracts, supplier agreements, and employee documents
- Human resources handles sensitive personal data tied to training, qualifications, and employment records
- Customer and supplier management systems overlap with QMS processes such as audits, evaluations, or complaints
All these activities generate information that is relevant for the QMS, but they also introduce new challenges. Sensitive data and personal records must be managed under strict information security and GDPR requirements. Without proper control, organizations face risks not only of non-compliance but of reputational damage and business disruption.
That’s why our Customizable QMS Software Solutions go beyond the boundaries of traditional quality systems. We ensure that:
- QMS workflows can be extended to cover related operational units
- Confidentiality, integrity, and availability of sensitive data are maintained
- Business continuity is supported through secure, connected processes
A secure and adaptable QMS is not just about compliance; it is about safeguarding the entire organization.
Questions & Answers
Yes, we can help you choose the right solution for you, either because you just decided to leave your current vendor, or you are first establishing a quality management system.
Together, we will analyze your current situation and define the requirements that are most important to you, and we can advise you which quality management system solution to choose.
We have the most experience in building quality management systems around the Atlassian or Microsoft suite, but we can evaluate any other software solution that would fit your needs.
For specific requirements and organizational setups, we also provide custom-made software solutions, fully developed by us.
Yes, this is something we specialize in, and this is something our customers benefit from the most.
If you need to build a complete quality management system from scratch, or you need our help with a specific area, we can first define your processes and then digitize them accordingly.
This way, you will receive well-defined internal processes, fully digitized and automated, working together as one complete solution.
There are two main factors you should take into consideration.
The first is the toolchain already implemented in your organization. If you already use Confluence or Microsoft as your core document management system, it’s worth evaluating whether your current setup covers all necessary areas required for a Quality Management System, and then focus only on improving the parts that do not work.
The second factor is the size and complexity of your organization. For larger companies, we usually recommend either a hybrid solution, where Confluence covers certain areas and Microsoft others, or to build the QMS entirely around Microsoft technologies such as SharePoint and the Power Platform, which provide higher robustness and scalability for enterprise environments.
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