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Quality Management Software Built for Medical Devices
Discover our qm-modules, specifically tailored to the demanding needs of medical device manufacturers. Our specialized solutions for medtech provide only the features you truly need.
We guide you reliably from the initial implementation to the validation of your quality management system – for quality that sets new standards.
Quality Management Software Built for Medical Devices
Why Industry-Specific Software For Medtech?
As a medtech company, you need more than just a generic QMS. Our software provides the features you need to comply with the highest regulatory standards. Specifically developed for the Life Science industry and GxP, it supports your quality management without unnecessary complexity or customization.
Work more efficiently, focus on your processes, and take advantage of features tailored specifically for medtech. Generic business solutions are a thing of the past: your industry has unique requirements.
More than just document management: your QM software should be the foundation of your MDR and ISO compliance strategy. We provide end-to-end lifecycle support for imaging systems, OR devices, monitoring, orthopedic implants, and lab tech – covering everything from initial development and clinical evaluation to risk management, CAPA, and audit-ready technical documentation.
Design control
Supplier and test equipment management
CAPA and deviation management
Inspection and audit management
Software validation
Secure quality management: From design control to post-market surveillance. Master the rigorous requirements of 21 CFR Part 11, ISO 13485, and EU-MDR with ease. Through automated workflows and precise corrective actions for non-conformities, you can optimize your production and maintain product quality consistently at the highest level. From document control and risk management to CAPA (Corrective and Preventive Actions)—we guarantee full traceability and validation.
Device and system providers
Gain a competitive edge with digital quality management tailored for ISO 13485 and MDR compliance. Our software streamlines your entire production, ensuring everything from design control to end-to-end traceability is optimized.
Seamless traceability and audit trails
Supplier management and qualification
UDI tracking for components
Validation of components
Through automated workflows for CAPA and preventive measures, we guarantee uncompromising product quality that wins over your OEM customers. Rely on the highest quality standards and GAMP 5-compliant validation.
Component manufacturers and OEMs
Navigating IVDR and ISO 13485 complexity is a challenge – our digital QMS is the answer. Built specifically for the IVD industry, our software manages the full product lifecycle, ensuring everything from analytical validation to comprehensive post-market performance is covered.
Performance management
Analytical/ Performative evaluation
Class-specific evaluation
Software validation
Benefit from the advantages of automated documentation that bundles all risk management and vigilance measures in a legally compliant manner. Ensure smooth market authorization and excellent product quality by managing testing and validation directly within the system – for medical devices that excel worldwide.
IVD manufacturers
Streamline the maintenance and repair of complex medical devices with our QM software. We guarantee full regulatory compliance – supporting everything from end-to-end UDI traceability to ISO 13485 performance audits.
Repair workflows
Traceability & UDI
Order management
Calibration management
Device history
By using digital workflows for repair logs and integrated CAPA measures, you minimize liability risks and guarantee a product quality that withstands even the strictest audits (MDR/IVDR).
Service and maintenance providers
In medtech distribution, logistics is the key to success. While manufacturers focus on R&D, we streamline your supply chain. Ensure regulatory peace of mind with end-to-end UDI tracking, GDP-compliant cold chain monitoring, and automated workflows that slash liability risks.
Batch traceability
Supplier management and qualification
Warehouse and logistics workflows
Incident management and escalation
Benefit from software that automates essential risk-mitigation measures and guarantees the product quality of your medical devices all the way to the end user—ensuring a stress-free experience during every audit. Our QM software complies with GDP (Good Distribution Practice), MDR/IVDR requirements, and ISO 13485 (for distributors), with a strong focus on cold chain monitoring, batch traceability, and UDI tracking. It supports automated warehouse processes, incident reporting, and manufacturer contracts to minimize liability risks and ensure constant audit readiness.
Medtech trade and distribution
Over 25 Years of Excellence in Life Sciences and GxP – Our References Speak for Themselves
Choose sustainability through experience. For over a quarter of a century, aiti GmbH has been guiding clients through the complex regulatory landscape. See our references for yourself and discover how our flexible modules can optimize your processes too.
Master MDR & ISO 13485: The Smart QM-Software for Medtech
Regulatory hurdles for medical device manufacturers are high. With our solutions, you can master every requirement and achieve full compliance effortlessly. Meet MDR, IVDR, ISO 13485:2016, and FDA 21 CFR Part 820 with ease.
This ensures your company is ready for future demands and can master any regulatory inspection with confidence.
Our platform offers holistic solutions to implement all regulatory requirements for medical technology in a systematic, traceable, and audit-proof manner. Audit-compliance is guaranteed! Our eQMS seamlessly documents all changes, approvals, and access logs – including electronic signatures in accordance with FDA 21 CFR Part 11.
From Paper to Digital: A QM Boost for Medical Technology
Safety and compliance, digitized. Create, manage, and archive your qm-documentation digitally and in a revision-secure manner.
Individually configurable templates, forms, and fields ensure standards-compliant documentation and seamless traceability – effortlessly and efficiently.
No more tedious searching for current versions or signatures. By automating recurring processes, you can save valuable time and focus on what matters most: the safety and quality of your medical devices.
Our software offers a role-based, user-friendly interface to ensure user satisfaction across the entire organization. Automated workflows, deadlines, notifications, and task management ensure clear responsibilities and timely completion.
Do you have any specific questions about digitalizing your qm-system or migrating your eQMS?
Discover how simple the transition can be and contact our expert team today.
Get Started Fast: QM-Software for Small and Mid-Sized Medtech Teams
Modular, scalable, efficient. Specialized QMS for MedTech SMEs: Discover how our platform optimizes your processes.
Your growing business deserves an agile qm-system. Our user-friendly software scales with your needs, allowing your team to hit the ground running. Choose a QMS that ensures compliance while streamlining your team’s workflow.
Start small. Scale big. The aiti suite is modular, scalable, and ideal for small to medium-sized medtech teams. Get a solution that grows with your needs—without unnecessary complexity.
Your needs. Your choice. Our platform consists of three flexible QM modules. You decide what you truly need – the modules can also be ordered individually to suit your specific requirements.
Document control made easy: Stop searching, stay current.
Efficient process management starts here.
Your training management, redefined.
Discover the advantages of our QM software: mitigate risks, streamline quality management, and prepare your team for upcoming audits. Quality that sets industry standards!
Our system guides you through validation, planning, and rollout—from secure product development to fast-track certification.
Your benefits at a glance
Focus on Compliance
Automation in quality management
TÜV-certified QM software
GAMP-validatable solutions
Data protection and integrity
Individual validation packages
Intuitive user interface
Flexible and agile QMS
Training and webinars
Our Top Features for Medtech Companies
Our core features include integrated document management, enabling version control, approval workflows, validity periods, and the controlled distribution of SOPs, work instructions, and forms.
Discover how our eQMS simplifies compliance with all requirements and efficiently leads manufacturers to success. Save time, optimize management, and support your team for sustainable product quality!
Streamlined QM documentation, CAPA, and action management. We offer a qm-system with industry-specific features designed to help you ensure the safety of your products.
Our top features for medtech
Document control
CAPA & action management
Supplier evaluation
Design control
Validation of components
Traceability & UDI
Audit management
Deviation management
Training matrix and LMS
Task and role management
Calibration management
Advantage in Medtech & GxP Through Knowledge
Advantage in Medtech & GxP Through Knowledge
In our blog, we share deep insights into the evolution of the qm-landscape and Regulatory Affairs for medical technology, medical devices, pharmaceuticals, and IVD. Take advantage of numerous free information materials, downloads, documents, and news to make your daily work more efficient and legally compliant. Whitepapers, case studies, and development templates are available for you at no cost.
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Premium Solutions, Expert Support: Your QM Success is Our Goal
aiti GmbH is your partner for the highest quality standards. From initial consultation to ongoing maintenance: we support you at every step of your qm-system implementation. Our service covers all phases.
We provide the assistance needed to optimize your processes, ensuring your products shine in every audit and for every customer. Our team offers professional validation support so that your quality management sets the benchmark. Choose our quality management system for medical technology – validated, GxP-compliant, and audit-ready.
Empower your organization through our expert knowledge and guidance.
Our services at a glance
Introductory workshops
Individual consulting
Maintenance and updates
Expert service and support
Key user training
Webinars and further education
Complex questions, clear answers: Our expertise for your qm software.
QM software is indispensable in industries such as medical technology, pharmaceuticals, IVD, and medical devices, as it helps companies consistently manage quality and safety while minimizing regulatory risks. This software solution mitigates risk through automated documentation, testing, and audit trails, allowing the team to work more efficiently and maintain a clear overview of processes. A digital qm-system promotes sustainability through digital workflows and scalable compliance. In the medical technology industry, qm-software is crucial for ensuring that your company reliably manages and proves high standards across all regulated sectors. With our GxP-compliant software solution, you take your management, team, and processes to a new level of quality and transparency.
High-quality qm software for medical technology meets standards such as ISO 13485, MDR/IVDR, GxP, and 21 CFR Part 11 to minimize risks and ensure successful audits. Our GxP-compliant platform unites all relevant regulatory requirements – from ISO 13485:2016 to the EU MDR – within a single system. Our software solutions support you in effortlessly mapping the strict mandates of the MDR/IVDR.
In full alignment with EU MDR (2017/745) and IVDR (2017/746), our platform connects qm-documentation with proactive CAPA and action management. Thanks to an integrated DMS and a strict role-based concept according to FDA 21 CFR Part 11, every review and electronic signature is secure. With robust audit management features, we ensure that your documents withstand all regulatory affairs requirements at any time – secure, transparent, and ready for retrieval.
Our platform supports medical device manufacturers in complying with the specific requirements of the MDR through industry-specific quality management workflows. The software ensures regulatory compliance with all relevant standards for medical devices, including automated documentation and audit trails.
Our eQMS is fully compliant with ISO 13485 and provides optimal support for manufacturers in the quality management of medical devices and equipment. Our qm-system meets all ISO 13485 requirements for traceability and integrity (Chapter 4). Integrated CAPA functions (Corrective and Preventive Actions) manage risk-based quality processes throughout the entire product lifecycle. From design controls to supplier management (Chapter 7) – your medical devices and their quality management system are seamlessly covered.
Our eQMS provides medical device manufacturers with a comprehensive solution for end-to-end control of all product lifecycle processes. This ensures that industry-specific quality management requirements are met efficiently – from planning and production to market launch and tracking. Automated workflows ensure the seamless implementation of quality controls, risk management, and documentation that precisely meet regulatory standards.
The validation of qm software in the medical technology sector is critical, as it provides documented evidence that the software is fit for its intended purpose, thereby ensuring the quality of products and processes. ISO 13485 and FDA 21 CFR 820.70 require a risk-based validation of the qm-system prior to initial use and following any changes to control impacts on production, service delivery, and monitoring.
Our software is not only fully validatable, but we also guide you through the entire validation process with tailored packages. Benefit from customized solutions and expert support for your internal processes.
