Requirement Libraries

These Predefined Requirement Sets can be downloaded and imported into your existing Aligned Elements projects to kickstart your documentation work.

Some of them require special templates, usually provided in the extension download.

Contact the Aligned Element Support Team for advice on how to apply these Requirements in the quickest possible way.

Johner Institute Medical Device IT Security Product Requirements

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.

IVDR (EU 2017/746) Annex I General Requirements

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.

MDR (EU 2017/745) Annex I General Requirements

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.

Generic Infusion Insulin Pump Requirements: Best Practice Examples

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.

Requirements for Electronic Instructions For Use (eIFU)

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

Generic Requirements for Medical Devices

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

FDA 21 CFR Part 11 Requirements

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