eQMS for Medical Devices & SaMD
Simplifying Regulatory Compliance for Medical Devices and SaMD
eQMS Innovation provides an electronic Quality Management System designed specifically for medical device and Software as a Medical Device (SaMD) organizations.
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The solution is built on Atlassian Jira and Confluence, transforming these powerful collaboration tools into a fully structured regulatory-compliant eQMS environment aligned with medical device quality standards.
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Our approach configures Jira and Confluence to support the processes required by regulatory frameworks such as ISO 13485, ISO 14971, IEC 62304, and FDA 21 CFR Part 820, helping organizations manage quality documentation, risk management, and product lifecycle traceability in a compliant and efficient way.
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Built on Atlassian Jira & Confluence for end-to-end traceability.
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Configured to meet regulatory expectations
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Designed for medical device and SaMD teams
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Built for Regulated Teams
Built for Medical Device Regulatory Requirements
Many organizations use tools like Jira and Confluence for development and documentation, but these tools alone do not meet the structured requirements expected in regulated environments.
eQMSInnovation bridges this gap by transforming the Atlassian ecosystem into a regulatory-ready quality management system. The system introduces controlled documentation processes, traceability between development artifacts, and structured workflows that align with quality and regulatory expectations.
This allows teams to continue working within familiar tools while maintaining the documentation structure required for regulatory audits and product approvals.
Centralized quality documentation management
End-to-end traceability between requirements, risks, and verification activities
Prebuilt templates support compliance with key industry standards, including ISO 13485, ISO 14971, IEC 62304, IEC 62366-1
Configurable workflows for quality processes
Secure electronic records and approvals
eQMS Implementation
Our implementation approach focuses on configuring Jira and Confluence to support the processes expected in a medical device Quality Management System.
Instead of introducing a separate enterprise QMS platform, eQMSInnovation builds directly on Atlassian tools already used by many organizations, reducing complexity while maintaining regulatory alignment.
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System Configuration
We configure your Jira and Confluence environment to support key quality processes, including document control, risk management, design controls, and change management.
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Quality Documentation Structure
Controlled document repositories and templates are established within Confluence to support compliant documentation management.
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Traceability Setup
Links are created between requirements, risk analysis, development tasks, verification activities, and documentation to support full lifecycle traceability.
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Team Onboarding
We provide onboarding and guidance to ensure your team understands how to use the system effectively while maintaining regulatory compliance and audit readiness.
Compliance with Key Industry Standards
Aligned with Medical Device Quality Standards
eQMS Innovation configures Atlassian Jira and Confluence to support the processes required by major medical device regulatory frameworks.
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These include:
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ISO 13485 – Medical Device Quality Management Systems
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ISO 14971 – Risk Management
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IEC 62304 – Software Lifecycle Processes
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IEC 62366-1 – Usability Engineering
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FDA 21 CFR Part 820 – Quality System Regulation
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ISO 27001 – Information Security
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GDPR – Data Protection
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By structuring workflows and documentation around these standards, organizations can maintain a compliant and audit-ready environment while continuing to work within the Atlassian ecosystem.
Why Choose eQMSInnovation
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Built on familiar Atlassian tools, but configured for regulatory compliance
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Prebuilt templates aligned with ISO 13485, ISO 14971, and MDR
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Rapid 1 month implementation for fast onboarding
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End-to-end traceability across product development lifecycle
Services Overview
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If your organization plan to implement an electronic quality management system compliant with ISO13485, 21CFR820, 21CFR 11, ISO9001, ISO27001, MDSAP, we can help you meet many of the requirements of these standards, by using Atlassian Jira® & Confluence® Software Integration.
As part of implementation, get our documentation templates for free!
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Do you need ISO 13485 or QMS MDR 2017/745 for an effective implementation of the New European Medical Device Regulations?
Our Regulatory Affairs and Quality Assurance team can help you understand, plan and implement both ISO 13485, and MDR 2017/745 QMS.
As part of implementation, get all our ISO 13485/MDR QMS templates for free!
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We help medical device manufacturers to meet the requirements of the Regulations on Medical Devices. We provide our expertise from help writing the regulatory strategy, guidance and support during all stages of product development, to review product technical files documentation for a successful product registration.