Risk management in medical device development has always lived in an interesting tension. On one side, there is the need for consistency, traceability, and compliance with standards such as ISO 14971. On the other side, there is the reality of how engineers and quality teams actually like to work: fast, visual, and with an overview that provide context.
At Aligned AG, we have built Aligned Elements to leverage integrated risk management. Aligned Elements connects risks directly to requirements, tests, and other Design Control artifacts, while also ensuring consistency through validation and inconsistency checks that help teams identify gaps early and achieve high quality with low effort.
However, one thing has been consistently clear from user feedback: while Aligned Elements offers far more power than spreadsheets, many users still value the clarity and speed of a grid-based view for working with risks.
That’s why we’re introducing a powerful new feature risk managers will truly value.
The Return of the Grid
Many users are intimately familiar with spreadsheet tools such as Excel. These tools offer speed and flexibility, but they lack the deep integration needed for regulated medical device development.
Aligned Elements already solves the integration problem by connecting risk management directly to Design Controls, requirements, and testing activities. What was missing for some users was the grid experience to support fast editing and review.
With the new Risk Grid feature, Aligned Elements reintroduces a spreadsheet-style interface without sacrificing re-use, traceability, or compliance.
This is a step forward that combines the best of both worlds: the speed and intuitiveness of a grid interface with the strength of an integrated risk management system. Users can now view, edit, and analyze risks in a unified view.
Familiar Structure, Smarter Reuse of Risk Components
A powerful aspect in Aligned's integrated risk management is the ability to structure and reuse key risk management components consistently. Instead of treating each risk as an monolithic entity, users can define and reuse risk elements such as Harms and Risk Control Measures.
With this structured approach, consistency across risk analyses increase and duplication efforts are significantly reduced.
Users can now work with these reusable components directly in a tabular format. We hope that this combination of reuse and a grid-based editing creates the appropriate balance between efficiency and rigor.
The helicopter perspective
Risk analysis is often about understanding relationships and patterns. When these elements are scattered across multiple screens or views, it naturaly becomes more cumbersome to mentally maintain the proper context in mind.
The Risk Grid solves this by bringing connected risk information together into a single, coherent view which is meant to improve both speed and understanding. Teams can identify patterns more easily and make better informed decisions during risk assessments and reviews
How people work with Risk Assessments
The introduction of the Risk Grid is about improving how people work.
It respects the way medical device professionals naturally think about risk management: in structured lists, comparisons, and relationships that are easy to scan and edit.
At the same time, it reinforces the strengths of Aligned Elements by ensuring that every change remains part of a fully traceable, integrated, and auditable design control environment.
We provide a result that feels natural, efficient, and powerful at the same time.
