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Assistants

The Regulatory Assistant extensions come in two flavours:

1) Some provide auto-generation of Design Controls based on questionnairs filled in by the user.

2) Other are guided Checklists where the questions are to be answered by drag and drop references to existing Design Controls.

OWASP Top 10 Cyber Security Checklist

This Assistant takes the shape of a Checklist where you assess your own medical device against the OWASP Top 10 security risks.

You start out by assessing whether the risk is applicable to your device at all, and if not, provide a qulified answer why this is not the case (the auditors rewards such qualifications!).

If the risk is applicable, you are required to refer to the Aligned Elements Design Control Items that addresses the risk by selecting them in the UI.
You can compare your risk reduction controls against known best-practice remidiations mentioned in the OWASP Top 10 list.

When the checklist is completed, a Regulatory Assistance item is generated, containing all steps and your provided answers. This information remains stored in Aligned Elements for compliance purposes.

The OWASP Top 10 Regulatory Assistant Checklist is free to all Aligned Elements customers and can be applied to any Aligned Elements Web Server installation.

Note! The OWASP Top 10 Regulatory Assistant Checklist only works in Aligned Elements.

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

When to Submit a 510(k) for a Software Change to an Existing Device
The FDA requires that medical device manufacturers submit a new 510(k) when a marketed device 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 guidance 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).

Electronic Instructions For Use (eIFU) Checklist (EU 207/2012)

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 at the conclusion of having a qualified device.

Aligned Elements Pre-Submission Checklist

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

IEC 62304 Checklist for your software requirements

Load this Wizard in Aligned Elements, run it, answer the questions and automatically generate an IEC 62304 checklist for your software requirements coverage according to IEC 62304 section 5.2.3.

Aligned Elements also offers a complete pre-configured configuration to achieve IEC 62304 compliance.

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.

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 "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.

All extension categories