Are you spending too much time on documentation?

Medical device documentation inefficiencies proliferate throughout the industry.

When the primary focus is compliance, the documentation process efficiency often gets overlooked.

Use our self-assessment to uncover, identify and eliminate inefficiencies in your organization.

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! 

Is the design documentation process delaying your product release?

Learn more about the best practices that speed up the DHF management process.

Save time, free up resources and ensure regulatory compliance.

Document your product once and use intelligent document reuse to save time and money.

If several of your medical devices contain the same components, it might make sense to modularize your DHF documentation.

Read more about how Tecan reduced its time to produce DHFs by applying a modular development documentation approach.

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. 

In this Risk Management survey, we cover the conventions used by four medical device companies to comply with ISO 14971. 

The complete Aligned Elements user manual available for download.

The reference document for the functionality of Aligned Elements.

The complete Aligned Elements user manual available for download.

The reference document for the functionality, administration and configuration of Aligned Elements.

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.