More Design Control Items
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.