Compliance with Regulations and Standards
QSR, FDA CFR 21 Part 820
Aligned Elements provides you with excellent design control as required by the Quality System Regulations (QSR).
Your DHF is maintained including all your requirements, specifications, tests, and risk artefacts.
End-to-end traceability, integrated version and review control, document management, and audit trail, all these things covered directly in Aligned Elements.
Aligned Elements has been designed to fulfill design control and reporting requirements from ISO 13485.
We will help you enforce your Quality Management System and manage the Technical File.
Aligned Elements not only manages Requirements or Tests but also reviews their status and also comes with solid support for your Risk Management.
Risk management for medical devices is a central part of the DHF. Whether you require a Preliminary hazard analysis (PHA) or an FMEA (or both), Aligned Elements will keep you covered.
We believe that a very important part when it comes to risk management is to maintain the analysis as an integrated part of your DHF.
Specifications may be analyzed for the FMEA, measures implemented by Requirements and thoroughly tested.
The usability engineering file is an integrated part of your DHF consisting of identifications of use cases, risk analysis of use scenarios and establishing corrective design.
Aligned Elements provides you with good tools for all of these disciplines also when it comes to reporting your usability engineering actions.
Cyber Security Risk Assessment templates help you assess the Cyber Assets, Threats, Vulnerabilities, and Adverse Impact of your system, in line with the FDA Cybersecurity Guidelines as well as AAIM TIR 57.
Conduct your medical device risk assessment in Aligned Elements and integrate the resulting Design Control Items in the overall development traceability.
EN 60601-1:2006, IEC 60601-1:2005
For Medical electrical equipment, one main burden on a medical device manufacturer lies in establishing the Risk Analysis required for the testing of compliance.
In this area, you can make good use of Aligned Elements to simplify the process by tracking potential hazards from 60601-1 into the Risk Analysis in Aligned Elements and also simplify the reporting by generating the TRF directly.
User Management in line with FDA 21 CFR Part 11 compliance
Aligned Elements implements the technical controls for 21 CFR Part 11. The integrated user management ensures that the right people in your organization have the correct access.
All changes to your DHF are tracked and Aligned Elements automatically captures the project audit trail.
In addition, we provide a prepared 21 CFR Part 11 assessment to be completed with your specific local procedural and administrative controls.