We have made these extensions available for download to speed up your work. Use them to save time, increase transparency or improve the quality of your Design History File.

General downloads

Download and import these extensions by clicking on the download link. Unzip the downloaded file. In Aligned Elements, right-click anywhere in the Project Explorer and select "Import" in the context menu. Follow the import instructions to complete the import. It is recommended that you first import the extension into a dummy project to get familiar with the content of the extension before applying it into a production environment.

This package contains predefined Potential Hazards, Causes and Harms derived from the IMDRF Terminologies for Categorized Adverse Event Reporting.

The lists are applicable to Aligned Elements projects using Risk Assessments using the Preliminary Hazard Analysis method. 

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Aligned Elements users can kick start their risk identification process by downloading and importing our ISO 14971:2012 Annex C Extension, assessing them and start generating risks and mitigation. 

The ISO 14971:2012 Annex C Extension contains:

  • RVT file for an ISO 14971 Annex C Question (becoming the ISO 24791 Annex A in the 2019 edition) and a corresponding DOCX Reporting style template
  • 42 importable questions built on Annex C in ISO 14971 to assess and integrate in your Risk Assessment

This Extension facilitates the assessment of the questions, the creation of both an automated assessment report of the Annex C questions as well as a starting point for generating new risks and mitigation. 

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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.

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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 with the intention of accelerating the documentation effort.

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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 a 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 will as the AAIM TIR 57 and include the risk assessment design controls in the overall development traceability.

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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 with the intention of accelerating the documentation effort.

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Exoskeleton manufacturers get and running with the Aligned Elements Exoskeleton Extension Package containing:

- 9 Potential Hazards (including suggested mitigations measures) outlined as exoskeleton associated risk factors by the FDA
- 38 exoskeleton Special Control Requirements deduced from 21 CFR Part 890 Docket No. FDA-2014-N-1903

This gives manufacturers a predefined starting point when setting up their Design History File with the intention of accelerating the documentation effort.

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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.

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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.

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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.

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

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In support of the Preliminary Hazard Analysis model in Aligned Elements, here are five PHA Harms based on the example Five Qualitative Severity Levels from ISO 14971 Table D. 3. 

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

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

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58 Requirements for Electronic Records and Electronic Signatures deduced from the FDA 21 CFR Part 11 regulation. 

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An example DHF Index containing 135 DHF Line Items.

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Import your Nunit results into Aligned Elements and populate your test results with a single click.

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Activate a wizard by downloading and unzipping the zip file, then place the content in your Wizard Directory (see Main Menu -> Wizards -> Set Wizard Directory). To run a Wizard, go to Main Menu -> Wizards -> Run Wizard and select the Wizard to run. 

The FDA requires that medical device manufacturers submit a new 510(k) when a marketed devices has changes, including changes to software, that could significantly affect the safety or effectiveness of the device or when there are major changes in the intended use of the device.
This wizard codifies the FDA guidence document "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" to help you assess whether your changes are significant and therefore will result in a new 510(k).

The COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices Article 3 stipulates the requirements for being qualified to this regulation on electronic instructions for use. This Checklist will capture and document objective evidence about how you arrive to the conclusion of having a qualified device.

Load this Checklist Wizard in Aligned Elements, run it, answer the questions and you will have performed a gap analysis of your current development documentation.

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