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

The Technical Report, IEC TR 80002-1 "Medical device software - Part 1 Guidance on the application of ISO 14971 to medical device software", takes a software angle on ISO 14971, just as the title suggests.

Annex B of the report elaborates on possible software hazards and factors to consider in order to properly assess whether and how they are applicable to a particular device. 

To assist the risk identification of software hazards, use this extension, inspired by the Annex B of IEC/TR 80002-1. 

It includes:

• RVT file for a Software Hazard aspect and a corresponding DOCX Reporting style template
• 70+ importable potential Software Hazards to assess and integrate into your Risk Assessment

You may of course expand this hazard list with hazards that are particular to your device and the conditions under which it needs to operate.

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 into 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. 

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. 

A great way of conducting a structured risk identification is to start off with a known list of potential hazards. ISO 14971:2012 Annex E (ISO 14971:2019 Annex E) provides such a list that can be downloaded and imported below.  

The ISO 14971 Hazard Examples contains:

• 74 importable potential Hazards built on Annex E in ISO 14971:2012 (ISO 14971:2019 Annex E) to assess and integrate into your Risk Assessment

The imported items correspond to the Hazard Design Control in the Aligned Elements FDA Templates. 

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. 

If you want to check how well your QMS complies with ISO 13485, you can use this Aligned Elements Extension in your Aligned Elements instance.

In an auditing situation, you might be required to demonstrate how you comply to this standard.

The Extension consists of:

• A new template called "Checklist Item" incl. a Word Template for this type
• 143 importable checklist items that cover chapter 4 to 8 in ISO 13485:2016
• Each item contains a control question, an assessment of the question and a placeholder for adding evidence for the assessment

Use this checklist to get a properly controlled and document proof of your compliance with ISO 13485.

If you develop software for a medical device then you have hopefully aligned your processes with IEC 62304 - Medical Device Software 

In an auditing situation, you might be required to demonstrate how you comply to this standard.

Our IEC 62304 Checklist is integrated in Aligned Elements and lets you perform the assessment inside AE, taking advantage of inconsistency rules, tracing to existing project documents as objective evidence and simple export to word once completed.

The checklist includes 93 prepared audit questions based on the requirements in IEC 62304.

This is a simple and efficient way to demonstrate your company and software's compliance with the standard.

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.

An example DHF Index containing 135 DHF Line Items.