Content Download

These preconfigured resources can be imported and used in your Aligned Elements Projects.

The downloads below uses the Aligned Elements default templates if nothing else is specified.

 

Regulatory Downloads

Potential Hazards interpreted from ISO 14971 (Price: 249 CHF)	A non-exhaustive list of possible hazards from ISO 14971 Annex D.
Requirements interpreted from FDA 21 CFR Part 11 (Price: 199 CHF)	58 Requirements for Electronic Records and Electronic Signatures deduced from the FDA 21 CFR Part 11 regulation.

 

Requirements

Generic Requirements for Medical Devices	This zip file contains over 70 generic requirements, typical for medical devices.
DIN EN980-2008 Requirements	This zip file contains over requirements derived from the norm DIN EN980-2008.

 

Wizards

Content generation wizard for DIN EN980-2008 Requirements	Load this Wizard in Aligned Elements, run it, answer the questions and automatically generate the requirements from DIN EN980-2008 that are applicable to your product.
Assessment wizard for "Classification of stand-alone software (MDD)"	Load this Wizard in Aligned Elements, run it, answer the questions and automatically generate an assessment of your software being considered a medical device according to the MDD.
Assessment wizard for "The MEDDEV guidelines on stand-alone software (IVD-D)"	Load this Wizard in Aligned Elements, run it, answer the questions and automatically generate an assessment of your software being considered a medical device according to the IVD-D.
Assessment wizard for "FDA Level of Concern"	Load this Wizard in Aligned Elements, run it, answer the questions and automatically generate an assessment of your product. The output is an evaluation of the products' Level of Concern (Major, Moderate, Minor) according to FDA.
Software Requirement Checklist derived from IEC 62304	Load this Wizard in Aligned Elements, run it, answer the questions and automatically generate an assessment of your software requirements coverage according to IEC 62304.

 

Nunit Integration

Files needed to import Nunit results into Aligned Elements

This zip file contains the necessary files to importa Nunit results into Aligned Elements.

 

Export Transformations

Export transformations are used to convert Aligned Elements object into other formats. Place the transformation file in the "TransformationMapping" directory in the template directory to make it accessible for the AE client.

To HTML	Generates an HTML document displaying the attribute content of the exported Document Objects (trace information is not included).
To Excel	Generates an Excel file containing the attribute content for the exported Document Objects (trace information is not included).
To CSV	Generates a CSV file containing the attribute content of the exported document objects.
Size Analysis	Generates an HTML report containing the Document Object byte size for all exported objects. Objects with a byte size in MB order are highlighted in red. (Works only with V1.7 and higher)
To Outlook Tasks	Generates a CSV file containin the Project Name, ID and Title of the exported Document Objects which can be imported as Outlook Tasks.

 

Export/Import Schema

Document Object XSD Schema

The XSD Shema specifying the Aligned Elements Document Object default XML format (used for export and import).

 

DHF Index Downloads

Example of DHF Index

An example DHF Index containing 135 DHF Line Items.

 

User Groups

Read-Only	In this user groups, only Read rights are activated.
Product Manager	The user groups only has access to Requirements and general object types.
Test Executor	The user groups only has access to object types relevant for Test Execution.

 

Queries

Risk Queries

Risk Critical Specificatons	This Query filters out Specifications that are traced from Mitigations, i.e. Design Changes made due to risk mitigations.
Test Cases for Risk Critical Specifications	This Query filters out Test Cases that are traced from Risk Critical Specifications.
Risk Critical Test Cases	Filters out failed test cases Test Cases traced from Mitigations, i.e. tests that verifies that mitigations have been correctly implemented.

 

Test Queries

Not Passed Tests	This Query filters out Executed Test Cases that have not been executed for a certain configuration.
Not Executed Test Cases	This Query filters out Test Cases that have never been executed.
Failed Test Cases	Filters out failed test cases for a certain configuration.
Untested Specifications or Use Cases	Filters out test cases for which no test case exists.

Requirement Quality Checks

The Queries below perform quality checks on the Requirement titles based on "rules" in Chapter 15 in Karl E. Wieger's book "More About Software Requirements".

Shall, Must, Will	A Requirement shall contain the word "shall" or "must" or will.
May, Might, Could, Should, Would	It is unclear weather requirements containing these words shall be implemented or not.
Negative Requirements	Specify what the product shall do. Not what it shall not do.
This/That	Presense of these prenouns can lead to unclear referals.
Ambiguous Adverbs	Checks for the existence of -ly words that can be ambiguous.

 

Ambiguous Adjectives

Searches for adjectives in the title that are known to cause ambiguity.

Ambiguous Adjectives A-G	This Query filters out Requirements that contains ambiguous adjectives from A-G e.g. "acceptable", "broad", "comfortable" etc.
Ambiguous Adjectives H-N	This Query filters out Requirements that contains ambiguous adjectives from H-N e.g. "large", "many", "numerous" etc.
Ambiguous Adjectives O-S	This Query filters out Requirements that contains ambiguous adjectives from O-S e.g. "quite", "satisfying", "short" etc..
Ambiguous Adjectives T-W	This Query filters out Requirements that contains ambiguous adjectives from T-W e.g. "typical" , "various", "workable" etc.