Regulatory Compliance

The European Union's Medical Device Regulation (MDR) regulates the medical device market in the EU.

Aligned Elements facilitates the generation and management of the Technical File including Design Control Management, Risk Management, V&V management as well as creating the Documents, reviews, approvals and signoffs.

Benefit from existing checklists and GSPR content to streamline your product development process, reduce the risk of errors and omissions, and ensure compliance with the MDR.

Just like for MDR, Aligned Elements supports Technical File Management including the management of Requirements, Risks, Verification, Validation, Document, Traceability and much more. 

Aligned Elements supports Design Development aligned with ISO 13485 and Risk Management aligned with ISO 14971.

The General Safety and Performance Requirements (GSPR:s) from Annex I in IVDR is available to all Aligned Elements customers as an importable data package to kickstart your IVDR development.

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.  

Use your Risk Analysis to apply the correct safety classification to your software items.

Depending on the classification Aligned Elements guides you to refine the documentation work with detailed design and unit testing.

You may in the same way capture the rationale for Safety Classification A.

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, IEC 80001, MDCG 2019-16 and other guidelines.

Conduct your medical device risk assessment in Aligned Elements and integrate the resulting Design Control Items in the overall development traceability.

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.