Technical File
At QC Analytics, we support organizations in preparing and maintaining a complete Technical File for medical devices, ensuring compliance with CE marking, FDA requirements, IEC 62304, and risk management (ISO 14971).
A well-structured Technical File is essential for demonstrating that your product is safe, effective, and compliant, enabling successful regulatory submissions and market entry.
What is a Technical File?
A Technical File is a comprehensive set of documentation that demonstrates your product’s conformity with applicable regulations and standards.
It includes detailed information on:
- Product design and development
- Manufacturing processes
- Risk management and safety
- Verification and validation activities
Technical documentation is required to prove compliance with EU regulations and support CE marking, and must be maintained and made available to authorities when requested.
CE Marking and FDA Submissions
We guide you through both European and US regulatory pathways, ensuring your Technical File meets all required expectations.
Our support includes:
- Identification of applicable regulatory requirements
- CE marking conformity assessment
- Preparation for FDA submissions (510(k), PMA, De Novo, HDE)
- Documentation review and gap analysis
- End-to-end submission support
A properly structured Technical File is essential for demonstrating compliance, safety, and performance to regulatory authorities.
Risk Management (ISO 14971)
Risk management is a core component of the Technical File and a regulatory requirement for medical devices.
We help you implement ISO 14971-compliant risk management processes, including:
- Hazard identification and risk analysis
- Risk evaluation and control measures
- Risk-benefit assessment
- Traceability between risks, requirements, and testing
Technical documentation must include a risk assessment and explanation of how risks are mitigated, ensuring product safety throughout its lifecycle.
IEC 62304 Software Lifecycle Integration
For software-based medical devices, compliance with IEC 62304 is essential and directly feeds into the Technical File.
We support:
- Software lifecycle planning and documentation
- Software safety classification
- Architecture and design documentation
- Verification and validation evidence
- Change management and maintenance processes
This ensures your software development is controlled, traceable, and aligned with regulatory expectations, forming a key part of your Technical File.
Building a Complete Technical File
We help you structure and compile all required documentation into a clear, audit-ready Technical File, including:
- Device description and specifications
- Design and development documentation
- Risk management files (ISO 14971)
- Software documentation (IEC 62304)
- Verification and validation reports
- Clinical and performance data
- Labeling and instructions for use
- Post-market surveillance documentation
A Technical File acts as the central evidence repository demonstrating compliance with regulatory requirements and supporting product lifecycle management.
The Next Steps
Contact QC Analytics to develop your Technical File and ensure your medical device meets all regulatory requirements with confidence and efficiency.