Medical Device eQMS
The Challenge: Traditional Quality Management Is Holding You Back
Medical device companies face rigorous regulatory requirements for CE marking in the EU or FDA authorisation in the US. Traditional quality management systems involve:
- Overwhelming paperwork and documentation
- Siloed information across multiple platforms
- Inefficient approval processes that delay product launches
- Limited collaboration between quality and development teams
- Higher costs from maintaining multiple systems
The Solution: A Fully Digital QMS on Platforms You Already Use
As a modern software development team, it is likely you are already using Atlassian's suite of products. Our electronic Quality Management System (eQMS) leverages the power of Atlassian's Confluence and Jira platforms to create a seamless, compliant, and efficient quality management solution specifically designed for medical device companies.
Why Choose Our Confluence & Jira-Based eQMS?
Seamless Integration with Your Development Workflow
Many medical device teams already use Jira for development before implementing a QMS. While standalone QMS solutions exist, they only pull information from Jira into their platform. Our solution:
- Maintains your existing Jira workflow
- Creates bidirectional links between Jira issues and Confluence QMS documentation
- Supports full traceability between requirements, issues, and quality records
- Eliminates the need to switch between multiple systems
- Limit additional licence cost from another tool.
Built for Regulatory Compliance
Our eQMS meets all essential regulatory requirements, including:
- Document Control - Compliant with ISO 13485:2016 §4.2.4, §4.2.5, and FDA 21 CFR 820.40
- Electronic Signatures - FDA 21 CFR Part 11 compliant approval workflows
- Version Control - Clear tracking of document revisions and change history
- Access Management - Ensuring documents are available only to authorized personnel
- Audit Readiness - Comprehensive traceability matrices and documentation
- Efficient Training Documentation – Training documentation on the QMS process is seamlessly integrated in the platform
Enhanced Team Collaboration
Traditional QMS solutions create barriers between quality and development teams. Our eQMS:
- Fosters collaboration between quality, regulatory, and development teams
- Creates transparency across the entire product lifecycle
- Enables remote work with secure access from anywhere
- Reduces the "quality tax" perception by integrating QMS into daily workflows
Key Features of Our Confluence & Jira eQMS
Document Management
- Automated document creation and templates
- Electronic approval workflows with 21 CFR Part 11 compliant signatures
- Clear separation between draft and approved documents
- Automatic versioning and revision history
- Branded PDF exports for regulatory submissions
Requirements & Design Controls
- Manage user needs and requirements in Jira
- Create traceability matrices automatically
- Link verification activities directly to requirements
- Generate design documentation from development activities
Release Management
- Automated creation of release documentation
- One-click traceability reports
- Significant time savings for mandatory release records
- Integration of development and quality activities
Services We Offer
We evaluate your current processes and workflows through workshops and gap analyses.
We customize Confluence and Jira with the necessary apps and templates.
We ensure your system meets all regulatory requirements as per ISO13485 Section 4.1.6.
We provide comprehensive training for your team.
We offer ongoing support to ensure your continued success.
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