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The Medical Device Cybersecurity Risk Assessment template pack contains:

- RVT templates defining Assets, Threats, Vulnerabilities and their associated Adverse Impacts and Counter Measures as well as corresponding Word Reporting style templates in A3 format

- Over 30 importable best practice cybersecurity mitigations

This allows the manufacturer to conduct Cybersecurity risk assessments in line with the FDA cybersecurity guidelines as well as the AAIM TIR 57 and include the risk assessment design controls in the overall development traceability.

Unzip the downloaded file. Place the rvt and docx file in your template folders. Import the xml file containing the Cyber Security Measures into Aligned Elements. When importing this extension, make sure that the "Recreate chapters" option is selected in the import dialog.

The Aligned Elements IEC 82304 configuration is a superset of the IEC 62304 configuration. It expands the IEC 62304 configuration with Product Use Requirements and Product Validation Tests. It has been tuned to automatically take care of most of the involved quality checks, making sure that the required tasks and actions are sufficiently covered.

The Aligned Elements IEC 82304 configuration contains:

• Pre-configured templates using IEC 82304 standard naming conventions
• Software Safety Classification automatically based on risk analysis results
• Numerous quality checks for consistency verification
• Pre-configured Reviews and checkpoints according to IEC 82304 and IEC 62304 stipulations
• Pre-configured Trace Tables based on the IEC 82304 and IEC 62304 requirements
• A set of document templates being a great starting point for your documentation
• 48 importable Product Use Requirements for Accompanying Documentation from IEC 82304

The Aligned Elements IEC 82304 supports documentation management of:

• Product Use Requirements
• Product Validation Tests and Results
• System and Software Requirements
• Software Architecture building blocks(Software Items, Units, SOUPs, and segregations)
• Risk Management using a Preliminary Hazard Analysis technique (listed in ISO 14971)
• Software Verification  (Unit, Integration and System testing)
• Change and configuration management (Problem Reports and Change Management)

Note! The Aligned Elements IEC 82304 configuration is a significantly large extension to apply. 

To get the proper understanding of the extension aspects, we strongly recommend that you book a live demonstration of the Aligned Elements IEC 82304 configuration, please This email address is being protected from spambots. You need JavaScript enabled to view it. to set up an appointment.

Computer System Validation often shortened as "CSV", concerns data processing systems are used as part of production or the quality system (from FDA QSR 820.70) or, as freely interpreted from ISO 13485:2016, all computerized systems being used in any of the processes regulated by the Quality Management System.

In its most basic form, a CSV plan should state the User Requirements, which captures the intended use of the systems. The User Requirements are then tested in IQ, OQ, and PQs, and the results of these tests and, if applicable, deviations are summarized in the Validation Report.

These kinds of tasks are easily performed in an ALM like Aligned Elements.

The Aligned Elements CSV Configuration

This lightweight configuration contains the basic elements for documenting the validation of a computer system.

It includes:

• Design Controls for User Requirements and Design Specifications
• Design Controls for Test Cases and Test Results
• Optional Design Controls for Risk Assessments
• Predefined Trace Tables
• Document Template examples for Validation Plans and Validation Reports
• Document Template examples for IQ, OQ, PQ Plan and Report

  

For medical device manufacturers with limited previous experience in usability engineering, the task of implementing IEC 62366-1 might seem intimidating. However, the updated 2015 version of the standard has simplified and clarified the required process steps and tasks and Aligned Elements now features a preconfigured IEC 62366-1:2015 setup that integrates the inputs, outputs and risk relevant elements of the usability process into the oveall Design Control traceability.

The IEC 62366-1:2015 configuration includes:

• 8 Design Control templates for capturing the input and output elements of the usability process
• Pre-configured content validation checks assessing the consistency of the project in real-time
• ISO 14971 compliant risk management to identify, assess and mitigate Use Error-driven risks
• Interactive Checklist for reviewing the Use Specifications Document against IEC 62366-1:2015 
• 20 usability example risks for Use Errors during the Transport, Storage, Installation and Decommissioning
• 2 preconfigured Traceability Tables
• Integrated test protocols for established test methods such as:
• Cognitive Walkthrough
• Heuristic Evaluation (based on the Nielsen-Schneidermann heuristics)
• Simulated-Use Testing for Usability Validation

The Aligned Elements IEC 62366-1:2015 configuration supports documentation management of:

• User Requirements and Specifications
• Risk Management using a Preliminary Hazard Analysis technique (listed in ISO 14971)
• Verification and Validation (Unit, Integration and System testing)
• Change and configuration management (Problem Reports and Change Management)

Note! The Aligned Elements IEC 62366 configuration is a significantly large extension to apply. 

To get the proper understanding of the extension aspects, we strongly recommend that you book a live demonstration of the Aligned Elements IEC 62366 configuration, please This email address is being protected from spambots. You need JavaScript enabled to view it. to set up an appointment.

Perform a Preliminary Hazard Analysis in Aligned Elements. Instructions for use can be found in the Aligned Elements User Manual Section 3.8

This zip file contains the necessary template files to conduct a PHA in Aligned Elements. Copy the RVT files to the template root directory. Copy the content of the RTFTemplate directory to the template RTFTemplate directory.

Getting compliant with IEC 62304 may seem daunting at first. The Aligned Elements IEC 62304 configuration has been set up to guide you through this process and has been tuned to automatically take care of most of the involved quality checks, making sure that the required tasks and actions are sufficiently covered.

The Aligned Elements IEC 62304 configuration contains:

• Pre-configured templates using IEC 62304 standard naming conventions
• Software Safety Classification automatically based on risk analysis results
• Numerous quality checks for consistency verification
• Pre-configured Reviews and checkpoints according to IEC 62304 stipulations
• Pre-configured Trace Tables based on the IEC 62304 requirements
• Included Process-checklists for documented verification of process compliance

The Aligned Elements IEC 62304 supports documentation management of:

• System and Software Requirements
• Software Architecture building blocks(Software Items, Units SOUPs, and segregations)
• Risk Management using a Preliminary Hazard Analysis technique (listed in ISO 14971)
• Verification and Validation (Unit, Integration and System testing)
• Change and configuration management (Problem Reports and Change Management)

Note! The Aligned Elements IEC 62304 configuration is a significantly large extension to apply. 

To get the proper understanding of the extension aspects, we strongly recommend that you book a live demonstration of the Aligned Elements IEC 62304 configuration, please This email address is being protected from spambots. You need JavaScript enabled to view it. to set up an appointment.