Requirement Management for medical device development. Regulatory demands on the requirement elicitation process and structure can have unforeseen effects.
Find out more about the particular implications induced by the medical device regulations during the design input elicitation process.
Traceability is a core concept in Medical Device design documentation.
Find out how the effect of the required traceability increases the DHF complexity and why paper based documentation is inherently inept to deal with the challenges of the constantly changing DHF trace structure.
Learn more about how Aligned Elements can speed up the medical device development process and free up valuable resources.
Aligned Elements is a Medical Device ALM software written for Medical Device experts by Medical Device experts, taking both daily ease-of-use as well as regulatory compliance challenges into account.
Compiling the Design History File takes a considerable effort, often significantly more than initially anticipated. There are, however, great optimizations waiting to be discovered once you take a close look at the DHF process!
The Aligned Elements importer is used to import DHF content from existing Word, Excel, and CSV files such as requirement documents, specifications, and risk assessments.
This user manual describes the configuration options available for the Aligned Elements document importer.
