Aligned Elements Template Sets contain templates that facilitate compliant documentation important standards in Medical Device Development.
All or parts of these template sets can be used in your existing configuration.
Contact Aligned Elements Support Team for advise on how to best incorporate them into your Design Control Structure.
It is recommended that you try out and inspect the downloaded template set in a test project before applying it in a production project.
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 14971:2012 Annex C) provides such a list that can be downloaded and imported below.
The ISO 14971 Hazard Examples contains:
The imported items correspond to the Hazard Design Control in the Aligned Elements FDA Templates.
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 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 well as the AAIM TIR 57 and include the risk assessment design controls in the overall development traceability.
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.
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.