Customer Stories and White Papers
Customer Stories and Design Control Management Best Practices and Lessons drawn from hundreds of Medical Device Development Cases.
Customer Stories
Customer Story - Connecting the Design Control Dots by Biotronik Vascular Intervention
From duplicated work, manual tracking and the looming risks of documentation inconsistencies to integrated, comprehensible Design Control Management.
Read more about how Biotronik streamlined their Design Control Management using Aligned Elements.
Customer Story - Sony's mSafety says, "Yes, you can"
Sony developed mSafety which combines a user-friendly wearable health/wellness device with a reliable back-end solution.
Read more about the development of mSafety and their reasoning for choosing Aligned Elements for Design Control Management.
Customer Story - Managing Medical Devices in 70 countries by pjur
For more than 25 years, the pjur group has supplied the global market with medical and cosmetic products
Read more about how pjur uses Aligned Elements to manage their portfolio of devices in 70 countries.
White Papers
DHF Best Practices
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.
Design Inputs Uncovered
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.
Modular DHF
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.
Regulatory Traceability
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.
Risk Management from the trenches
In this Risk Management survey, we cover the conventions used by four medical device companies to comply with ISO 14971.
Six steps to easier DHF Management
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 road to efficiency
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.
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