The eQMS built for medical device startups
BaxQ gives medical device, IVD and SaMD companies access to enterprise-grade quality management software from just £60 per user per month. Built on Cognidox technology, it provides a structured quality management framework developed by experienced Regulatory Affairs and Quality Assurance professionals, giving organisations a practical compliance foundation from day one.
Designed specifically for regulated industries, BaxQ supports the management of your Quality Management System, Design History File (DHF), Risk Management File and Technical Documentation within a single controlled environment. The framework can be tailored to your organisation using BaxMed’s proven templates, processes and guidance, helping you establish a QMS that is both compliant and operationally relevant to the way your business works.
Whether you choose to configure the system yourself, adapt the BaxMed framework to suit your organisation, or work with BaxMed to create a fully operational, ISO 13485-ready QMS, BaxQ provides the platform, structure and expertise to support your growth from concept through to commercialisation.
Introduction
Enterprise-grade eQMS technology with a practical starting point
Simplifying the process
Building a quality management system from scratch can be a significant challenge for growing medical device companies. BaxQ helps simplify that process by combining the proven Cognidox platform with a structured quality management framework developed by experienced Regulatory Affairs and Quality Assurance professionals.
Compliant and relevant
Rather than starting with a blank system, organisations gain a practical compliance foundation that can be tailored to their products, processes and ways of working. The result is a quality management system that is both compliant and operationally relevant, providing a strong platform for future growth and certification activities.
Accelerated implementation
By starting from an established framework, organisations benefit from greater certainty around implementation effort, project timelines and investment requirements. Whether you choose to configure the system yourself or work with BaxMed to accelerate implementation, BaxQ provides a clear and structured route towards building an effective quality management system and preparing for certification.
key features
What BaxQ gives you
BaxQ is a fully featured electronic quality management system designed to support the complete lifecycle of a medical device, from early development through to commercialisation and post-market activities. Beyond core quality management processes, BaxQ provides the structure needed to manage your Design History File (DHF), Risk Management File and Technical Documentation within a single controlled environment.
Built on the Cognidox platform, BaxQ includes:
- Electronic document control with version control, configurable approval workflows, audit trails, and metadata indexing
- Design controls to manage your design history file (DHF), design inputs and outputs, and phase-gated development documentation
- Corrective and preventive action (CAPA) management and non-conformance reporting
- Supplier management and complaints handling
- Change management and post-market surveillance documentation
- An integrated learning management system (LMS) with skills matrix, training assessments, and trainer sign-off
- FDA 21 CFR part 11 compliant e-signatures
- Software validation documentation, including Installation Qualification (IQ) and Operational Qualification (OQ), with Performance Qualification (PQ) protocols and execution support available through BaxMed
- Support for organisations operating within GxP-regulated environments
- Risk management documentation aligned with ISO 14971 principles
Consistent and auditable
Each quality process is managed through a structured Quality Module containing process guidance, linked documentation and controlled records. New records can be created directly from the relevant module, helping ensure consistency across the system while maintaining complete traceability and auditability.
This structured approach makes it easier for users to navigate the system and provides a clear, logical framework for notified bodies, certification auditors and regulatory inspectors reviewing your quality records.
The dashboard is fully configurable and can be tailored to different user roles, providing visibility of outstanding reviews, training activities, tasks, requests and key quality metrics. Below are examples of how BaxQ can be configured to support different organisational needs.
Here’s some screenshots showing how the system could look for you:
Support from real QA/RA professionals
Many software platforms provide ticketing systems, chatbots and self-service knowledge bases. BaxQ is different. Every BaxQ system includes access to an integrated support chat that connects directly with the BaxMed team, giving you access to experienced Regulatory Affairs and Quality Assurance professionals when you need practical guidance and support.
Packages & Pricing
Clear deliverables. Predictable costs. Scalable support.
BaxQ is available in a range of packages designed to provide organisations with a clear and scalable route to compliance. From a single-user eQMS licence through to a fully implemented, Stage 1-ready ISO 13485 quality management system, each package has been developed to provide predictable costs, defined deliverables and the flexibility to grow with your organisation.
Package 1:
Platform
Access the BaxQ platform with everything you need to manage controlled quality records within a secure and validated eQMS environment.
Ideal for:
Organisations that already have their own quality management documentation and processes
What’s Included:
BaxQ licences from 1 user
Enterprise-grade Cognidox eQMS platform
eQMS user training
Installation Qualification (IQ) documentation
Operational Qualification (OQ) documentation
Direct support from the BaxMed team
Pricing:
From £60 per user per month
Minimum 12-month contract
Package 2:
QMS Foundation
Build your own ISO 13485 quality management system using BaxMed’s structured framework, templates and implementation guidance.
Ideal for:
Organisations with internal quality expertise that want to accelerate implementation using BaxMed’s proven framework, templates and guidance.
What’s Included:
Everything in Package 1
ISO 13485:2016 Self-Implementation Pack
Quality Manual template
Policies, SOPs and Work Instructions
Forms, registers and implementation guidance
Structured Quality Modules for key quality processes
Practical templates developed by QA/RA professionals
Integrated support chat with direct access to the BaxMed team
Up to 10 hours of implementation support and guidance
Pricing:
From £60 per user per month
Plus £3,000 one-off implementation pack
Package 3:
DHF & Technical File Add-on
Extend your Package 2 QMS Foundation with structured Design History File and Technical Documentation frameworks aligned to your regulatory pathway.
Ideal for:
Medical device, IVD and SaMD companies developing products and preparing technical documentation alongside their quality management system.
What’s Included:
Everything in Package 2
Design History File (DHF) framework
Design and Development templates
Risk Management File structure
Technical Documentation framework
UK MDR, EU MDR or EU IVDR aligned templates
Guidance on linking DHF outputs to Technical Documentation
Pricing:
Available as an add-on to the QMS Foundation package.
Contact us for pricing.
Package 4:
Full Implementation
A complete quality management system implementation delivered by BaxMed, providing a structured and predictable route to a Stage 1-ready ISO 13485 quality management system. BaxMed develops and configures the quality management system on your behalf, tailoring documentation, processes, training and system configuration to your organisation’s products, activities and regulatory requirements.
Ideal for:
Organisations that want expert support to establish a compliant and operationally effective quality management system without building it themselves.
What’s Included:
• Everything in Package 2
• BaxMed-led QMS implementation
• Quality Management System tailored to your organisation
• Configuration of Quality Modules and documentation structure
• Full ISO 13485 practical use training
• Stage 1 audit readiness support
• Clear implementation plan, timeline and deliverables
Pricing:
£30,000 plus BaxQ licences
Typical Timeline:
Approximately 3 months
Why Stage 1 Ready?
Achieving Stage 1 readiness can be planned with a greater level of predictability because the quality management system, processes, documentation and training activities are within the scope of the implementation project. Progressing to Stage 2 certification requires the organisation to operate the system and generate objective evidence demonstrating effective implementation. BaxMed can provide ongoing support during this period through ad hoc consultancy or retainer arrangements, allowing organisations to access expertise when needed while retaining ownership of their quality management system.
Whether you choose a self-managed approach or a fully implemented quality management system, BaxQ provides a platform that can grow with your organisation. Additional Regulatory Affairs and Quality Assurance services are available across all packages, allowing you to access expert support exactly where and when it is needed.
Expert Support & Additional Services
BaxMed’s Regulatory Affairs and Quality Assurance team can provide additional support on any BaxQ package, allowing organisations to access expertise exactly where and when it is needed.
Training
• eQMS user training
• QMS process training (Document Control, CAPA, Supplier Management, Management Review and more)
• Full ISO 13485 practical use training
Validation
• Performance Qualification (PQ) support
• Client-specific validation activities
Quality Assurance Support
• Ad hoc quality assurance support
• Internal audits
• ISO 13485 gap assessments
• Audit preparation and remediation
• Quality Management Representative services
Regulatory Affairs Support
• Ad hoc regulatory affairs support
• Design History File development
• Technical Documentation development
• Certification support
• Post-market compliance support
• Regulatory Department retainer services
Documentation & Templates
• Individual QMS document templates
• QMS process document packs
• Design History File templates
• Technical Documentation templates
Retainer Services
• Outsourced Quality Department
• Outsourced Regulatory Affairs Department
• Ongoing compliance management and support
Already using Cognidox?
BaxMed can provide configuration, optimisation, workflow development, validation and quality system support regardless of who originally implemented your system.
Cognidox Support & Implementation
• Cognidox implementation support
• Cognidox configuration and optimisation
• Workflow design and development
• Quality Module setup and configuration
• Performance Qualification (PQ) protocol development and execution support
• Support for existing Cognidox environments
• Migration planning and system expansion
Trusted partners
BaxQ powered by Cognidox: a proven platform with a practical compliance framework
BaxQ combines the flexibility and support of BaxMed with the proven Cognidox eQMS platform used by medical device and life science organisations worldwide. Rather than building on a bespoke or proprietary system, BaxQ provides access to an established platform with a long track record of supporting regulated environments.
This means organisations benefit from enterprise-grade document control, quality management and traceability capabilities from day one, while also gaining access to BaxMed’s structured compliance framework, implementation guidance and ongoing support.
The Cognidox platform supports organisations operating under ISO 13485, ISO 9001, FDA 21 CFR Part 11, FDA 21 CFR Part 820, MDSAP and MHRA GxP requirements. For IVD companies, BaxQ can also support the management of documentation aligned to EU IVDR requirements.
grow together
Grow beyond BaxQ when you’re ready
One of the most important decisions a startup makes about its quality management system is whether it can grow with the business. Migrating from one eQMS to another mid-growth is costly, disruptive and risky.
BaxQ has been designed to provide organisations with an accessible entry point to the Cognidox platform, allowing them to establish their quality management system on the same underlying technology used by larger regulated organisations and scale when their requirements evolve.
Because BaxQ is built on Cognidox, organisations can transition seamlessly to a full Cognidox subscription when their requirements change. Your documents, structure, processes and records move with you, eliminating the need for a complex migration project or the disruption associated with implementing an entirely new platform.
For organisations requiring additional configuration, workflow development, validation support or system optimisation as they scale, BaxMed can also provide Cognidox implementation and support services, helping ensure the platform continues to meet the needs of the business as it grows.
Organisations that choose BaxQ can establish their quality management system on a proven platform from the outset, with a clear path to scaling their quality and regulatory activities as the business grows.
Contact
Get in touch
Contact us today to learn more about how BaxMed Regulatory Ltd can empower your organisation to thrive in a highly regulated environment. Together, we can turn regulatory and quality challenges into opportunities for growth and innovation.