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

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.

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

The Johner Institute has in collaboration with TÜV SÜD, TÜV Nord and Dr. Heidenreich (Siemens) compiled an excellent set of Medical Device IT Security Process and Product requirements.

The entire guideline is available in the GitHub-Repository „IT Security Guideline“ (https://github.com/johner-institut/it-security-guideline/).

This extension contains the 50 Product IT Security Requirements, which make up the second part of the guideline.

The IVDR (EU 2017/746) Annex I General Requirements extension contains:

- RVT file for an EU IVDR  Requirement and a corresponding DOCX Reporting style templates

- Over 129 importable Requirements derived from Annex I in IVDR (EU 2017/746)

This gives IVD medical device manufacturers a predefined starting point when setting up their technical file with the intention of accelerating the documentation effort.

The MDR (EU 2017/745) Annex I General Requirements extension contains:

- RVT file for an EU MDR  Requirement and a corresponding DOCX Reporting style templates

- Over 133 importable Requirements derived from Annex I in MDR (EU 2017/745)

This gives medical device manufacturers a predefined starting point when setting up their technical file with the intention of accelerating the documentation effort.

How to write good requirements? This set of requirements examplifies how to specify the Safety Design Input of a Generic Insulin Infusion pump (GIIP). 120 requirements in six major sections include best practice examples of how to specify insulin administration, alarms and warnings, user interface, battery management and much more. The requirements are deduced from an article in Journal of Diabetes Science and Technology. They are not elicited from any particular standard or regulation.

38 Requirements extracted from the EUs Commision Regulation No207/2012 on electronic instructions for use of medical devices (eIFU). 

This compilation contains over 70 generic requirements, typical for medical devices.