qmsWrapper is designed specifically for medical device startups, scale-ups, and small to medium-sized manufacturers that need a practical Quality Management System without the complexity of traditional enterprise platforms.
It is particularly well suited for organizations developing medical devices, Software as a Medical Device (SaMD), and related healthcare technologies that must comply with standards such as ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR.
Typical users include:
Quality Managers and Quality Engineers
Regulatory Affairs professionals
Design and Development teams
R&D Engineers
Risk Managers
CAPA coordinators
Technical Documentation specialists
Operations and Manufacturing teams
Company founders responsible for quality and regulatory compliance
Many of our customers are implementing their first electronic QMS after managing documents in Word, Excel, email, or shared folders. Others already have an established quality system and need a connected platform that supports CAPA, change control, risk management, technical documentation, traceability, post-market activities, and audit readiness.
Because qmsWrapper is built around three connected editions: Foundation, Lifecycle, and Vigilance, companies can start with the functionality they need today and expand without replacing or rebuilding their Quality Management System.
qmsWrapper helps medical device companies replace disconnected documents, spreadsheets, and manual processes with one connected Quality Management System that grows with their business.
Instead of implementing a large enterprise platform from day one, organizations can begin with controlled documents, forms, approvals, workflows, and training through Foundation. As their quality system matures, they can extend into Lifecycle to manage CAPA, quality events, change control, risk management, technical documentation, supplier quality, and traceability. Vigilance adds post-market surveillance, regulatory oversight, audit readiness, and management visibility.
The platform connects quality records instead of storing them in isolated modules. Documents, quality events, risks, training, technical documentation, and traceability remain linked throughout the product lifecycle, providing complete visibility and reducing manual effort.
Built-in AI assists users by helping draft records, identify missing information, connect related evidence, and perform semantic searches. Every AI-assisted activity remains under human control and is fully traceable, ensuring that regulated decisions always remain with qualified personnel.
The result is a Quality Management System that improves efficiency, supports regulatory compliance, and scales with the organization without requiring future migrations to another platform.
qmsWrapper is designed for quality professionals, not IT specialists.
Most users have backgrounds in quality assurance, regulatory affairs, engineering, manufacturing, or operations rather than software development. The platform provides intuitive workflows, guided processes, configurable forms, and role-based permissions that allow organizations to begin using the system with minimal technical knowledge.
Companies implementing Foundation can usually begin working with controlled documents, forms, approvals, and training after onboarding and initial configuration.
As organizations grow into Lifecycle and Vigilance, additional workflows and quality processes can be introduced gradually without disrupting existing data or requiring a complete system redesign.
Every customer receives free onboarding, training, and ongoing technical support. Our team also provides assistance through email, Microsoft Teams, and Zoom to help customers configure and use the platform effectively.
Most electronic Quality Management Systems are designed as large enterprise platforms that require organizations to implement everything at once.
qmsWrapper takes a different approach.
Instead of forcing companies into unnecessary complexity, it allows medical device organizations to build their Quality Management System progressively through three connected editions: Foundation, Lifecycle, and Vigilance.
Another key differentiator is qmsWrapper's connected architecture. Rather than treating documents, CAPAs, risks, technical files, training, and quality events as isolated modules, the platform connects them into a single quality ecosystem. This creates end-to-end traceability across the entire product lifecycle.
qmsWrapper also combines AI assistance with human-controlled quality processes. AI helps users complete records, identify missing information, connect related documents, and search quality data more efficiently while maintaining complete auditability and regulatory accountability.
Designed specifically for medical device companies, qmsWrapper supports internationally recognized regulations and standards, including ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR.
The result is a practical, scalable Quality Management System that grows with organizations from their first controlled documents to full regulatory and post-market oversight.
qmsWrapper operates within the medical device Quality Management System (eQMS) market.
Some of the best-known solutions include:
Greenlight Guru
Qualio
MasterControl
QT9 QMS
Simple QMS
While these platforms offer strong quality management capabilities, many are designed primarily for larger organizations or require companies to implement a broad set of functionality from the beginning.
qmsWrapper focuses on helping medical device startups and SMEs implement quality systems progressively. Organizations can begin with Foundation and expand into Lifecycle and Vigilance as their quality processes, regulatory obligations, and business grow, without rebuilding their Quality Management System or migrating to another platform.
Many Quality Management Systems offer similar modules: document control, CAPA, risk management, training, and audits. The difference lies in how those modules work together and how easily companies can adopt them.
qmsWrapper was designed specifically for medical device startups and SMEs that want to build a Quality Management System progressively instead of implementing a large enterprise platform all at once.
Unlike many competitors, qmsWrapper grows through three connected editions: Foundation, Lifecycle, and Vigilance. Companies start with the capabilities they need today and add more advanced functionality as their products, regulatory obligations, and quality processes mature. There is no need to migrate to another system or rebuild existing data.
Another key advantage is the platform's connected architecture. Documents, quality events, CAPAs, changes, risks, training, technical documentation, and traceability remain linked throughout the product lifecycle instead of existing as isolated modules. This provides complete visibility, simplifies audits, and reduces duplicate work.
qmsWrapper also combines AI assistance with human-controlled quality management. AI helps users draft records, identify missing information, connect related evidence, and search quality data, while every regulated decision remains under human review with a complete audit trail.
For organizations looking for a practical, scalable eQMS that supports long-term growth rather than unnecessary complexity, qmsWrapper offers a flexible alternative to traditional enterprise systems.
qmsWrapper is continuously evolving to help medical device companies manage quality, regulatory compliance, and product lifecycle activities more efficiently.
Recent developments include the introduction of three connected editions: Foundation, Lifecycle, and Vigilance, allowing organizations to implement only the functionality they need while maintaining a single connected Quality Management System.
Ongoing development focuses on expanding AI-assisted quality workflows, improving traceability across quality and design documentation, strengthening regulatory readiness, and increasing automation while maintaining full human oversight and auditability.
Customers can also expect continued improvements to Technical File management, Quality Events, CAPA workflows, risk management, post-market surveillance, regulatory reporting, AI governance, and integrations that reduce manual administrative work.
As regulations and industry expectations evolve, qmsWrapper continues to expand its capabilities while maintaining its core philosophy: helping organizations build connected, scalable Quality Management Systems that grow with their business.
qmsWrapper integrates with Jira, enabling development teams and quality teams to stay connected throughout the product lifecycle.
The platform also supports AI connectivity through the Model Context Protocol (MCP), allowing organizations to securely connect approved AI assistants to selected qmsWrapper data while maintaining user permissions, audit trails, and human oversight.
Our integration strategy focuses on connecting quality processes without compromising regulatory compliance, traceability, or data integrity. Additional integrations continue to evolve as customer requirements and regulatory expectations develop.
qmsWrapper uses a transparent subscription model built around three connected editions.
Foundation starts at €3,499 per year and includes unlimited users. It provides the core capabilities required to establish a controlled digital Quality Management System, including document control, workflows, forms, approvals, training, and AI-assisted quality processes.
Lifecycle builds on Foundation by adding connected quality workflows such as Quality Events, CAPA Lifecycle, Change Control, Risk Management, Technical File management, Smart Traceability Matrix, Supplier Quality, and related functionality. Pricing is tailored to each organization based on its requirements.
Vigilance extends Lifecycle with advanced post-market surveillance, regulatory oversight, management review, audit readiness, AI governance, and additional compliance capabilities. Pricing is available upon request.
Additional storage can be added as needed.
The best way to evaluate qmsWrapper is through a personalized live demonstration.
During the demo, our team learns about your current Quality Management System, regulatory requirements, and organizational maturity before recommending the most appropriate edition: Foundation, Lifecycle, or Vigilance.
Evaluation options may be discussed after the demonstration where appropriate. To schedule a demo or learn more about qmsWrapper, please contact our team.
Every qmsWrapper customer receives onboarding and product training to help their team successfully implement and use the platform.
Training covers both the software and recommended workflows, enabling organizations to build their Quality Management System step by step. Because qmsWrapper is implemented progressively, training can also be delivered in phases as additional functionality is introduced.
Customers also receive access to how-to documentation and ongoing guidance from our support team.
If organizations require specialist regulatory or Quality Management consulting beyond software implementation, we can introduce experienced independent consultants who work with medical device companies.
Implementation begins with understanding the organization's current Quality Management System, regulatory requirements, and business objectives.
Many customers start with Foundation, replacing manual documents, spreadsheets, and email-based approvals with controlled digital processes. As quality systems mature, additional capabilities from Lifecycle and Vigilance can be introduced without rebuilding existing data.
Typical implementations take a few weeks, although the exact timeline depends on factors such as company size, existing documentation, current quality processes, and regulatory maturity.
Every implementation includes onboarding, training, and ongoing support to help customers successfully adopt the platform.
All qmsWrapper customers receive ongoing product support at no additional cost.
Support includes:
Email support
Microsoft Teams support
Zoom support
Free onboarding
Product training
How-to documentation and user guidance
Our support team helps customers configure and use qmsWrapper effectively. While we are a software company rather than a regulatory consulting firm, we can connect customers with experienced Quality Management and regulatory consultants whenever specialist expertise is required.
Yes.
qmsWrapper includes AI-assisted capabilities designed specifically for regulated Quality Management Systems.
Rather than replacing quality professionals, AI supports them by helping draft records, identify missing information, connect related quality evidence, perform semantic searches, and improve efficiency across quality processes.
All AI-assisted activities remain human-controlled. Users review and approve every regulated decision, and all AI interactions are fully traceable through audit logs and user permissions.
The platform also supports Model Context Protocol (MCP), enabling organizations to securely connect approved AI assistants to selected qmsWrapper information while maintaining governance, security, and regulatory compliance.
Our approach is simple: AI should reduce administrative effort while preserving accountability, traceability, and human responsibility, principles that are essential in regulated medical device environments.
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